457 lines
No EOL
182 KiB
XML
457 lines
No EOL
182 KiB
XML
<?xml version="1.0" encoding="utf-8"?>
|
||
<!DOCTYPE html PUBLIC "-//W3C//DTD XHTML 1.0 Transitional//EN" "http://www.w3.org/TR/xhtml1/DTD/xhtml1-transitional.dtd">
|
||
<html xmlns="http://www.w3.org/1999/xhtml" xml:lang="en" lang="en">
|
||
|
||
<head><meta http-equiv="Content-Type" content="text/html; charset=utf-8" />
|
||
<!-- AppResources meta begin -->
|
||
<meta name="paf-app-resources" content="" />
|
||
<script type="text/javascript">var ncbi_startTime = new Date();</script>
|
||
|
||
<!-- AppResources meta end -->
|
||
|
||
<!-- TemplateResources meta begin -->
|
||
<meta name="paf_template" content="" />
|
||
|
||
<!-- TemplateResources meta end -->
|
||
|
||
<!-- Logger begin -->
|
||
<meta name="ncbi_db" content="books" /><meta name="ncbi_pdid" content="book-toc" /><meta name="ncbi_acc" content="NBK577895" /><meta name="ncbi_domain" content="niceng132er8" /><meta name="ncbi_report" content="printable" /><meta name="ncbi_type" content="fulltext" /><meta name="ncbi_objectid" content="" /><meta name="ncbi_pcid" content="/NBK577895/?report=printable" /><meta name="ncbi_app" content="bookshelf" />
|
||
<!-- Logger end -->
|
||
|
||
<title>Evidence review for bisphosphonates - NCBI Bookshelf</title>
|
||
|
||
<!-- AppResources external_resources begin -->
|
||
<link rel="stylesheet" href="/core/jig/1.15.2/css/jig.min.css" /><script type="text/javascript" src="/core/jig/1.15.2/js/jig.min.js"></script>
|
||
|
||
<!-- AppResources external_resources end -->
|
||
|
||
<!-- Page meta begin -->
|
||
<meta name="robots" content="INDEX,FOLLOW,NOARCHIVE,NOIMAGEINDEX" /><meta name="author" content="National Guideline Centre (UK)" /><meta name="citation_title" content="Evidence review for bisphosphonates" /><meta name="citation_publisher" content="National Institute for Health and Care Excellence (NICE)" /><meta name="citation_date" content="2019/05" /><meta name="citation_author" content="National Guideline Centre (UK)" /><meta name="citation_pmid" content="35167211" /><meta name="citation_fulltext_html_url" content="https://www.ncbi.nlm.nih.gov/books/NBK577895/" /><link rel="schema.DC" href="http://purl.org/DC/elements/1.0/" /><meta name="DC.Title" content="Evidence review for bisphosphonates" /><meta name="DC.Type" content="Text" /><meta name="DC.Publisher" content="National Institute for Health and Care Excellence (NICE)" /><meta name="DC.Contributor" content="National Guideline Centre (UK)" /><meta name="DC.Date" content="2019/05" /><meta name="DC.Identifier" content="https://www.ncbi.nlm.nih.gov/books/NBK577895/" /><meta name="og:title" content="Evidence review for bisphosphonates" /><meta name="og:type" content="book" /><meta name="og:url" content="https://www.ncbi.nlm.nih.gov/books/NBK577895/" /><meta name="og:site_name" content="NCBI Bookshelf" /><meta name="og:image" content="https://www.ncbi.nlm.nih.gov/corehtml/pmc/pmcgifs/bookshelf/thumbs/th-niceng132er8-lrg.png" /><meta name="twitter:card" content="summary" /><meta name="twitter:site" content="@ncbibooks" /><meta name="bk-non-canon-loc" content="/books/n/niceng132er8/toc/" /><link rel="canonical" href="https://www.ncbi.nlm.nih.gov/books/NBK577895/" /><link rel="stylesheet" href="/corehtml/pmc/css/figpopup.css" type="text/css" media="screen" /><link rel="stylesheet" href="/corehtml/pmc/css/bookshelf/2.26/css/books.min.css" type="text/css" /><link rel="stylesheet" href="/corehtml/pmc/css/bookshelf/2.26/css/books_print.min.css" type="text/css" /><style type="text/css">p a.figpopup{display:inline !important} .bk_tt {font-family: monospace} .first-line-outdent .bk_ref {display: inline} </style><script type="text/javascript" src="/corehtml/pmc/js/jquery.hoverIntent.min.js"> </script><script type="text/javascript" src="/corehtml/pmc/js/common.min.js?_=3.18"> </script><script type="text/javascript">window.name="mainwindow";</script><script type="text/javascript" src="/corehtml/pmc/js/bookshelf/2.26/books.min.js"> </script>
|
||
|
||
<!-- Page meta end -->
|
||
<link rel="shortcut icon" href="//www.ncbi.nlm.nih.gov/favicon.ico" /><meta name="ncbi_phid" content="CE8E3F667D73BCE10000000000A80084.m_5" />
|
||
<meta name='referrer' content='origin-when-cross-origin'/><link type="text/css" rel="stylesheet" href="//static.pubmed.gov/portal/portal3rc.fcgi/4216699/css/3852956/3985586/3808861/4121862/3974050/3917732/251717/4216701/14534/45193/4113719/3849091/3984811/3751656/4033350/3840896/3577051/3852958/3984801/12930/3964959.css" /><link type="text/css" rel="stylesheet" href="//static.pubmed.gov/portal/portal3rc.fcgi/4216699/css/3411343/3882866.css" media="print" /></head>
|
||
<body class="book-toc">
|
||
<div class="grid no_max_width">
|
||
<div class="col twelve_col nomargin shadow">
|
||
<!-- System messages like service outage or JS required; this is handled by the TemplateResources portlet -->
|
||
<div class="sysmessages">
|
||
<noscript>
|
||
<p class="nojs">
|
||
<strong>Warning:</strong>
|
||
The NCBI web site requires JavaScript to function.
|
||
<a href="/guide/browsers/#enablejs" title="Learn how to enable JavaScript" target="_blank">more...</a>
|
||
</p>
|
||
</noscript>
|
||
</div>
|
||
<!--/.sysmessage-->
|
||
<div class="wrap">
|
||
<div class="page">
|
||
<div class="top">
|
||
|
||
<div class="header">
|
||
|
||
|
||
</div>
|
||
|
||
|
||
|
||
<!--<component id="Page" label="headcontent"/>-->
|
||
|
||
</div>
|
||
<div class="content">
|
||
<!-- site messages -->
|
||
<div class="container content">
|
||
<div class="source">
|
||
<div class="pre-content"><div><div class="bk_prnt"><p class="small">NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.</p></div></div></div>
|
||
<div class="main-content lit-style" itemscope="itemscope" itemtype="http://schema.org/Book"><div class="meta-content fm-sec"><div class="iconblock whole_rhythm clearfix no_top_margin"><a href="https://www.nice.org.uk" title="National Institute for Health and Care Excellence (NICE)" class="img_link icnblk_img" ref="pagearea=logo&targetsite=external&targetcat=link&targettype=publisher"><img class="source-thumb" src="/corehtml/pmc/pmcgifs/bookshelf/thumbs/th-niceng132er8-lrg.png" alt="Cover of Evidence review for bisphosphonates" /></a><div class="icnblk_cntnt"><h1 id="_NBK577895_"><span itemprop="name">Evidence review for bisphosphonates</span></h1><div class="subtitle">Hyperparathyroidism (primary): diagnosis, assessment and initial management</div><p><b>Evidence review H</b></p><p><i>NICE Guideline, No. 132</i></p><p class="contrib-group"><h4>Authors</h4><span itemprop="author">National Guideline Centre (UK)</span>.</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">2019 May</span>.<div class="small">ISBN-13: <span itemprop="isbn">978-1-4731-3415-7</span></div></div><div><a href="/books/about/copyright/">Copyright</a> © NICE 2019.</div></div></div></div><div class="body-content whole_rhythm" itemprop="text"><div id="ch8.s1"><h2 id="_ch8_s1_">1. Bisphosphonates</h2><div id="ch8.s1.1"><h3>1.1. Review question: What is the clinical and cost effectiveness of bisphosphonates in people with primary hyperparathyroidism?</h3></div><div id="ch8.s1.2"><h3>1.2. Introduction</h3><p>People with primary hyperparathyroidism (PHPT) may have reduced bone mineral density, which increases the risk of fragility fractures. Bisphosphonates are a class of drug that reduces bone loss and increase bone mineral density. Oral bisphosphonates have no appreciable and sustained effects in lowering serum calcium. The aim of this review is to ascertain the clinical and cost-effectiveness of bisphosphonates, including in people not eligible for surgery and in people post-surgery.</p></div><div id="ch8.s1.3"><h3>1.3. PICO table</h3><p>For full details, see the review protocol in <a href="#ch8.appa">appendix A</a>.</p></div><div id="ch8.s1.4"><h3>1.4. Clinical evidence</h3><div id="ch8.s1.4.1"><h4>1.4.1. Included studies</h4><p>A search was conducted for randomised controlled trials assessing the effectiveness of bisphosphonates for treatment of people with primary hyperparathyroidism. The bisphosphonates were to be compared against the following: placebo, no treatment, calcimimetics, surgery or combination treatment.</p><p>Three studies were included in the review.<a class="bk_pop" href="#ch8.ref4"><sup>4</sup></a><sup>,</sup>
|
||
<a class="bk_pop" href="#ch8.ref5"><sup>5</sup></a><sup>,</sup>
|
||
<a class="bk_pop" href="#ch8.ref15"><sup>15</sup></a> These are summarised in <a class="figpopup" href="/books/NBK577895/table/ch8.tab2/?report=objectonly" target="object" rid-figpopup="figch8tab2" rid-ob="figobch8tab2">Table 2</a> below. Evidence from these studies is summarised in the clinical evidence summary tables below (<a class="figpopup" href="/books/NBK577895/table/ch8.tab3/?report=objectonly" target="object" rid-figpopup="figch8tab3" rid-ob="figobch8tab3">Table 3</a> and <a class="figpopup" href="/books/NBK577895/table/ch8.tab4/?report=objectonly" target="object" rid-figpopup="figch8tab4" rid-ob="figobch8tab4">Table 4</a>). See also the study selection flow chart in <a href="#ch8.appc">appendix C</a>, study evidence tables in <a href="#ch8.appd">appendix D</a>, forest plots in <a href="#ch8.appe">appendix E</a> and GRADE tables in <a href="#ch8.appf">appendix F</a>.</p><p>In the three studies, the participants were either all or mostly osteoporotic (defined as BMD T-score ≤ −2.5). All participants were women except in one study<a class="bk_pop" href="#ch8.ref15"><sup>15</sup></a> in which a third of the participants were men. The bisphosphonates were given orally in all the studies. Two studies compared alendronate with placebo<a class="bk_pop" href="#ch8.ref5"><sup>5</sup></a><sup>,</sup>
|
||
<a class="bk_pop" href="#ch8.ref15"><sup>15</sup></a>; one compared alendronate with vitamin D supplements against vitamin D only<a class="bk_pop" href="#ch8.ref4"><sup>4</sup></a>. The participants in the study Cesareo 2015<a class="bk_pop" href="#ch8.ref4"><sup>4</sup></a> were all normocalcaemic (generally defined as serum adjusted calcium ≤ 2.6 mmol/litre); this study was analysed separately under the normocalcaemic stratum. It should be noted that all participants in this study had osteoporosis (and therefore, also had bone end-organ effects according to our protocol). All the other studies were considered together in our stratum of people with bone end-organ effects and hypercalcaemic PHPT.</p><p>No studies were identified comparing bisphosphonates to calcimimetics, surgery or combination treatment.</p></div><div id="ch8.s1.4.2"><h4>1.4.2. Excluded studies</h4><p>See the excluded studies list in <a href="#ch8.appi">appendix I</a>.</p></div><div id="ch8.s1.4.3"><h4>1.4.3. Summary of clinical studies included in the evidence review</h4><p>See <a href="#ch8.appd">appendix D</a> for full evidence tables.</p></div><div id="ch8.s1.4.4"><h4>1.4.4. Quality assessment of clinical studies included in the evidence review</h4><div id="ch8.s1.4.4.1"><h5>1.4.4.1. Results stratum: People with normocalcaemic PHPT and presence of bone end-organ effects</h5></div><div id="ch8.s1.4.4.2"><h5>1.4.4.2. Results stratum: People with hypercalcaemic PHPT and presence of bone end-organ effects</h5><p>See <a href="#ch8.appf">appendix F</a> for full GRADE tables.</p></div></div></div><div id="ch8.s1.5"><h3>1.5. Economic evidence</h3><div id="ch8.s1.5.1"><h4>1.5.1. Included studies</h4><p>No relevant health economic studies were identified for this question.</p></div><div id="ch8.s1.5.2"><h4>1.5.2. Excluded studies</h4><p>No health economic studies that were relevant to this question were excluded due to assessment of limited applicability or methodological limitations.</p><p>See also the health economic study selection flow chart in <a href="#ch8.appg">appendix G</a>.</p></div><div id="ch8.s1.5.3"><h4>1.5.3. Unit costs</h4><p>The committee advised that the predominate bisphosphonates currently prescribed for treatment of PHPT are alendronic acid (oral) and zoledronic acid (intravenous). The prices for these two bisphosphonates were presented to the committee for consideration. Alendronic acid is available in a number of different formulations (e.g. sugar free) which are priced differently. For the purpose of cost effectiveness considerations the lowest priced option has been included.</p><p>The committee noted that there would also be a significant cost to deliver bisphosphonates intravenously, which would usually be a day-case delivery. As the NHS Reference costs do not include an entry for IV delivery of bisphosphonates, this cost is estimated using the reference cost of a day case delivery of simple parenteral chemotherapy (at first attendance), which is assumed to cover the cost of a day case admission of a drug by infusion. Therefore the delivery cost for zoledronic acid is estimated to be £260 (SB12Z).</p></div></div><div id="ch8.s1.6"><h3>1.6. Resource impact</h3><p>The recommendations made by the committee based on this review are not expected to have a substantial impact on resources.</p></div><div id="ch8.s1.7"><h3>1.7. Evidence statements</h3><div id="ch8.s1.7.1"><h4>1.7.1. Clinical evidence statements</h4><div id="ch8.s1.7.1.1"><h5>1.7.1.1. Alendronate + Vitamin D versus Vitamin D only in people with normocalcaemic PHPT and presence of bone end-organ effects</h5><p>There was a clinically important benefit of Alendronate + Vitamin D for Lumbar spine BMD (1 study, n=30; follow up 12 months; Low quality). There was no difference between Alendronate + Vitamin D and Vitamin D only for Incidence of hypercalcaemia or hypercalciuria (1 study, n=30; follow up 12 months; Low quality). No evidence was identified for health-related quality of life; mortality; deterioration in renal function; fractures; occurrence of kidney stones; cardiovascular events; adverse events; cancer incidence.</p></div><div id="ch8.s1.7.1.2"><h5>1.7.1.2. Alendronate versus placebo in people with hypercalcaemic PHPT and presence of bone end-organ effects</h5><p>There was a clinically important benefit of Alendronate for lumbar spine BMD (1 study, n=40; follow up 48 weeks; Low quality). There was no difference between Alendronate and placebo for distal radius BMD (1 study, n=40; follow up 48 weeks; Very Low quality); number of fractures (1 study, n=37; follow up 12 months; Low quality); number of serious adverse events (1 study, n=40; follow up 48 weeks; Very Low quality) and number of adverse events (1 study, n=37; follow up 12 months; Low quality). No evidence was identified for health-related quality of life; mortality; deterioration in renal function; occurrence of kidney stones; persistent hypercalcaemia; cardiovascular events; cancer incidence.</p></div><div id="ch8.s1.7.1.3"><h5>1.7.1.3. Bisphosphonates versus calcimimetics</h5><p>No evidence was identified.</p></div><div id="ch8.s1.7.1.4"><h5>1.7.1.4. Bisphosphonates versus surgery</h5><p>No evidence was identified.</p></div><div id="ch8.s1.7.1.5"><h5>1.7.1.5. Bisphosphonates versus combination treatment (calcimimetics and bisphosphonates)</h5><p>No evidence was identified.</p></div></div><div id="ch8.s1.7.2"><h4>1.7.2. Health economic evidence statements</h4><p>No relevant economic evaluations were identified.</p></div></div><div id="ch8.s1.8"><h3>1.8. The committee’s discussion of the evidence</h3><div id="ch8.s1.8.1"><h4>1.8.1. Interpreting the evidence</h4><div id="ch8.s1.8.1.1"><h5>1.8.1.1. The outcomes that matter most</h5><p>The committee considered the outcomes of health-related quality of life and mortality as critical outcomes for decision making. Other important outcomes included deterioration in renal function, fractures, occurrence of kidney stones, persistent hypercalcaemia, BMD (lumbar spine or distal radius), cardiovascular events, adverse events and cancer incidence.</p><p>No evidence was identified for the critical outcomes of HRQOL and mortality and the important outcomes of deterioration in renal function; occurrence of kidney stones; cardiovascular events; and cancer incidence.</p></div><div id="ch8.s1.8.1.2"><h5>1.8.1.2. The quality of the evidence</h5><p>Three studies were identified in total, all comparing oral bisphosphonates to no bisphosphonate administration. Two studies compared alendronate with placebo and the other study compared alendronate plus vitamin D supplements against vitamin D alone. No studies were identified comparing bisphosphonates to calcimimetics, surgery or combination treatment. No evidence was found for the use of IV bisphosphonates in people with primary hyperparathyroidism.</p><p>The evidence was split into strata according to the protocol. The first stratum was people with normocalcaemic primary hyperparathyroidism and the presence of bone end-organ effects. The second stratum was people with hypercalcaemic primary hyperparathyroidism and the presence of bone end-organ effects. The protocol definition for someone having bone end-organ effects was either a history of fragility fractures or osteoporosis (BMD T-score <−2.5 at any site). The evidence for the normocalcaemic primary hyperparathyroidism stratum completely matched this protocol definition, as people were only included in the study if they had osteoporosis. However, the evidence for the hypercalcaemic primary hyperparathyroidism stratum was less clear as to the proportion of people who had bone end-organ effects. One study stated that the included participants were ‘generally osteoporotic’ with no other details given except for a mean baseline BMD T-score of −2.54 ± 1.25 at lumbar spine and −3.58 ± 1.43 at distal third of radius. The other study included people with a T-score <−1.0 at ≥1 skeletal site, and stated that >60% had osteoporosis. The committee agreed that this evidence should be analysed in the ‘presence of end-organ effects’ stratum, but this uncertainty decreased the committee’s confidence in the evidence. No evidence was identified in people without bone end-organ effects, nor was any evidence identified for the protocol strata of pregnant women or people who have had previous parathyroidectomy.</p><p>All of the evidence was of Low or Very Low quality due to risk of bias and imprecision, decreasing the confidence that the effect estimate represents the true effect that would be seen in the guideline population.</p></div><div id="ch8.s1.8.1.3"><h5>1.8.1.3. Benefits and harms</h5><p>For people with normocalcaemic primary hyperparathyroidism and the presence of bone end-organ effects, there was a clinical benefit of bisphosphonates on the lumbar spine BMD. No person in either arm developed a change in hypercalcaemia during the study and therefore there was no clinical difference of bisphosphonates on this outcome. No other outcomes were reported for this stratum.</p><p>For people with hypercalcaemic primary hyperparathyroidism and the presence of bone endorgan effects, there was a clinical benefit of bisphosphonates on the lumbar spine BMD. There was no clinical difference for the outcomes of the distal radius BMD, number of fractures, number of serious adverse events and number of adverse events.</p><p>The committee highlighted that alendronate is often associated with upper GI events and even hospitalisation, but that this was not reflected in the available evidence. From clinical experience the committee agreed that alendronate can cause problematic GI side effects. The committee noted that taking oral alendronate can be inconvenient for people as they need to take the drug in the morning and remain in an upright position for half an hour. IV administration of bisphosphonates is sometimes used immediately before surgery. No evidence was found in this review for the use of IV bisphosphonates in people with primary hyperparathyroidism looking at bone density and fracture outcomes. However, the committee was aware of cohort studies for their use perioperatively to control calcium homeostasis, which is not within our scope. The committee noted that the included study sample sizes were small and that the studies would not have been powered to detect a difference in fractures.</p><p>The committee discussed that the lumbar spine BMD often sees a greater response to bisphosphonates due to the proportion of trabecular bone within the vertebrae. This is reflected in the evidence, with a clinical benefit of bisphosphonates on the lumbar spine BMD but not the distal radius BMD.</p><p>The committee agreed that bisphosphonates should be considered in people with primary hyperparathyroidism and bone end organ effects, to reduce fracture risk in line with NICE guideline on <a href="https://www.nice.org.uk/guidance/cg146" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">osteoporosis: assessing the risk of fragility fracture</a>. The committee agreed that the use of bisphosphonates should be considered in both people who will and will not go on to have surgery. The committee from their experience noted that in people with primary hyperparathyroidism, both oral and intravenous bisphosphonates lower serum calcium levels transiently and are sometimes used in acute treatment, but are inefficient in maintaining lower serum calcium-levels in the long term. The committee from their clinical experience discussed the pre-operative use of intravenous bisphosphonate therapy to reduce hypercalcaemia. While this may help reduce serum calcium if the level is very high, the committee did not advocate this approach.</p><p>The committee discussed that fracture risk may remain elevated in people after successful parathyroidectomy and felt that bisphosphonates would be appropriate to help improve BMD and reduce fracture risk in these patients.</p><p>Bisphosphonates have shown benefit in postmenopausal women with osteoporosis, and the committee agreed that there is no reason this benefit would be any different in people with primary hyperparathyroidism. The committee was aware of the recommendations in NICE’s technology appraisal guidance on bisphosphonates for treating osteoporosis.</p><p>The committee discussed that bisphosphonates do not act to reduce hypercalcaemia in the long term and hence agreed that a bisphosphonate should not be offered for long-term management of hypercalcaemia in primary hyperparathyroidism.</p><p>The committee discussed that, in people who are cured after parathyroid surgery, skeletal recovery can take some time and the use of bisphosphonates in this population needs to be carefully considered on an individual case basis.</p><p>Although there was no evidence available for intravenous bisphosphonates, the committee was comfortable in extrapolating evidence from oral bisphosphonates to intravenous bisphosphonates, as oral bisphosphonates are considered to be less potent and cause fewer adverse effects than intravenous bisphosphonates.</p><p>The committee noted that serum-calcium concentration needs to be monitored during treatment<a class="bk_pop" href="#ch8.ref11"><sup>11</sup></a>.</p><p>The committee noted that there was a very rare risk of bisphosphonate-related osteonecrosis of the jaw (ONJ) and/or atypical femoral fracture (AFF). ONJ and AFF are associated with both oral and IV bisphosphonates (more notable with IV) and are thought to be caused by trauma to bones that have a limited capacity for healing due to the effects of bisphosphonate therapy retained within the skeleton. The committee hence discussed the importance of warning patients about these risks, as this may have an impact on quality of life and future care.</p></div></div><div id="ch8.s1.8.2"><h4>1.8.2. Cost effectiveness and resource use</h4><p>No relevant health economic evaluations were identified for this question. Unit costs were presented to the committee to aid their consideration of cost effectiveness.</p><p>The majority of bisphosphonates are taken via oral delivery. The annual cost of oral bisphosphonates (alendronic acid) in the UK is estimated to be around £7.82, given the recommended weekly dose of 70 mg. IV bisphosphonates (zoledronic acid) are given once annually, and have an annual drug cost of around £13.24. Delivery of IV bisphosphonates usually takes place as a day case in hospital. The cost of delivery for IV bisphosphonates was estimated to be around £260, using a proxy measure of the NHS reference cost for day case delivery of simple parenteral chemotherapy as the cost of delivering a drug by intravenous infusion. However, the committee noted that actual costs may vary significantly depending on the location and type of clinic where the drug is delivered, and could range from £130 to £800. Hence, the impact on healthcare resource is highly dependent on where IV delivery takes place.</p><p>While evidence on the clinical effectiveness of bisphosphonates is uncertain from this review, the committee noted that both oral and IV bisphosphonates are recommended in TA464 for treating osteoporosis, and hence have previously been assessed as being a cost effective treatment. Bisphosphonates are currently recommended for people eligible for a risk assessment for osteoporosis and who have a risk of fracture greater than 1% (for oral bisphosphonates) or 10% (for IV bisphosphonates). In accordance with this guidance, people with primary hyperparathyroidism are eligible for risk assessment for osteoporosis as primary hyperparathyroidism is listed as a risk factor for ‘other causes of secondary osteoporosis’. The committee considered that under this guidance the majority of the primary hyperparathyroidism population are likely to be eligible for bisphosphonates.</p><p>As also reflected in TA464, the committee discussed that due to the high administration cost of IV bisphosphonates this treatment should be limited to those who are intolerant to oral bisphosphonates. It is estimated that around one-third of patients will experience side effects of alendronic acid, however it is unclear what proportion of these patients will receive IV delivery. While the committee acknowledges that the cost associated with IV bisphosphonates is potentially high, this cost is likely to be outweighed by costs associated with clinical events such as fragility fractures, which the patient is at risk of experiencing in the absence of treatment via bisphosphonates. Hence, the committee is of the opinion that bisphosphonates in either form of delivery are a cost effective intervention.</p><p>The committee discussed that bisphosphonates are also likely to be an effective and cost effective treatment for reducing fracture risk associated with the loss of bone density as a result of hypercalcaemia in people with primary hyperparathyroidism. This is due to the low cost of treatment and the avoided costs and disutility associated with the reduced fracture risk, which is likely to be sufficiently large for bisphosphonates to be considered cost effective.</p><p>Overall, bisphosphonates are a low-cost drug, and the recommendation in this guideline is in line with current standard practice. Consequently, this recommendation is not expected to have a significant resource impact.</p></div><div id="ch8.s1.8.3"><h4>1.8.3. Other factors the committee took into account</h4><p>As bisphosphonates do not provide a cure for the underlying condition of primary hyperparathyroidism, it was emphasised that they should not be considered as an alternative to curative measures such as surgery. Therefore it is important that patients are given the full context of this treatment to ensure that bisphosphonates are not considered by the patient as an alternative to surgery.</p></div></div></div><div id="ch8.rl.r1"><h2 id="_ch8_rl_r1_">References</h2><dl class="temp-labeled-list"><dt>1.</dt><dd><div class="bk_ref" id="ch8.ref1">Akbaba
|
||
G, Isik
|
||
S, Ates Tutuncu
|
||
Y, Ozuguz
|
||
U, Berker
|
||
D, Guler
|
||
S. Comparison of alendronate and raloxifene for the management of primary hyperparathyroidism. Journal of Endocrinological Investigation. 2013; 36(11):1076–82 [<a href="https://pubmed.ncbi.nlm.nih.gov/24081023" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 24081023</span></a>]</div></dd><dt>2.</dt><dd><div class="bk_ref" id="ch8.ref2">Brardi
|
||
S, Cevenini
|
||
G, Verdacchi
|
||
T, Romano
|
||
G, Ponchietti
|
||
R. Use of cinacalcet in nephrolithiasis associated with normocalcemic or hypercalcemic primary hyperparathyroidism: results of a prospective randomized pilot study. Archivio Italiano di Urologia, Andrologia. 2015; 87(1):66–71 [<a href="https://pubmed.ncbi.nlm.nih.gov/25847900" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 25847900</span></a>]</div></dd><dt>3.</dt><dd><div class="bk_ref" id="ch8.ref3">Casez
|
||
JP, Tschopp
|
||
P, Sandberg Tschopp
|
||
A, Lippuner
|
||
K, Zingg
|
||
E, Jaeger
|
||
P. Effects of nasal calcitonin on bone mineral density following parathyroidectomy in patients with primary hyperparathyroidism. Hormone Research. 2003; 59(6):263–9 [<a href="https://pubmed.ncbi.nlm.nih.gov/12784089" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 12784089</span></a>]</div></dd><dt>4.</dt><dd><div class="bk_ref" id="ch8.ref4">Cesareo
|
||
R, Stasio
|
||
E, Vescini
|
||
F, Campagna
|
||
G, Cianni
|
||
R, Pasqualini
|
||
V
|
||
et al. Effects of alendronate and vitamin D in patients with normocalcemic primary hyperparathyroidism. Osteoporosis International. 2017; 26(4):1295–302 [<a href="https://pubmed.ncbi.nlm.nih.gov/25524023" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 25524023</span></a>]</div></dd><dt>5.</dt><dd><div class="bk_ref" id="ch8.ref5">Chow
|
||
CC, Chan
|
||
WB, Li
|
||
JK, Chan
|
||
NN, Chan
|
||
MH, Ko
|
||
GT
|
||
et al. Oral alendronate increases bone mineral density in postmenopausal women with primary hyperparathyroidism. Journal of Clinical Endocrinology and Metabolism. 2003; 88(2):581–7 [<a href="https://pubmed.ncbi.nlm.nih.gov/12574184" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 12574184</span></a>]</div></dd><dt>6.</dt><dd><div class="bk_ref" id="ch8.ref6">Commercial Medicines Unit (CMU), Department of Health. Electronic market information tool (EMIT) [Last updated 5 January 2018]. 2011. Available from: <a href="http://cmu.dh.gov.uk/electronic-market-information-tool-emit/" ref="pagearea=cite-ref&targetsite=external&targetcat=link&targettype=uri">http://cmu<wbr style="display:inline-block"></wbr>.dh.gov.uk<wbr style="display:inline-block"></wbr>/electronic-market-information-tool-emit/</a> Last accessed: 05/10/2018.</div></dd><dt>7.</dt><dd><div class="bk_ref" id="ch8.ref7">Eller‐Vainicher
|
||
C, Palmieri
|
||
S, Cairoli
|
||
E, Goggi
|
||
G, Scillitani
|
||
A, Arosio
|
||
M
|
||
et al. Protective effect of denosumab on bone in older women with primary hyperparathyroidism. Journal of the American Geriatrics Society. 2018; 66(3):518–524 [<a href="https://pubmed.ncbi.nlm.nih.gov/29364518" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 29364518</span></a>]</div></dd><dt>8.</dt><dd><div class="bk_ref" id="ch8.ref8">Hamdy
|
||
NAT, Gray
|
||
RES, McCloskey
|
||
E, Galloway
|
||
J, Rattenbury
|
||
JM, Brown
|
||
CB
|
||
et al. Clodronate in the medical management of hyperparathyroidism. Bone. 1987; 8(Suppl. 1):S69–S77 [<a href="https://pubmed.ncbi.nlm.nih.gov/2961358" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 2961358</span></a>]</div></dd><dt>9.</dt><dd><div class="bk_ref" id="ch8.ref9">Hassani
|
||
S, Braunstein
|
||
GD, Seibel
|
||
MJ, Brickman
|
||
AS, Geola
|
||
F, Pekary
|
||
AE
|
||
et al. Alendronate therapy of primary hyperparathyroidism. Endocrinologist. 2001; 11(6):459–64</div></dd><dt>10.</dt><dd><div class="bk_ref" id="ch8.ref10">Horiuchi
|
||
T, Onouchi
|
||
T, Inoue
|
||
J, Shionoiri
|
||
A, Hosoi
|
||
T, Orimo
|
||
H. A strategy for the management of elderly women with primary hyperparathyroidism: a comparison of etidronate therapy with parathyroidectomy. Gerontology. 2002; 48(2):103–8 [<a href="https://pubmed.ncbi.nlm.nih.gov/11867933" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 11867933</span></a>]</div></dd><dt>11.</dt><dd><div class="bk_ref" id="ch8.ref11">Joint Formulary Committee. British National Formulary (BNF) September 2017. 2017. Available from: <a href="http://www.bnf.org.uk" ref="pagearea=cite-ref&targetsite=external&targetcat=link&targettype=uri">http://www<wbr style="display:inline-block"></wbr>.bnf.org.uk</a> Last accessed: 18/09/2018.</div></dd><dt>12.</dt><dd><div class="bk_ref" id="ch8.ref12">Khan
|
||
A, Bilezikian
|
||
J, Bone
|
||
H, Gurevich
|
||
A, Lakatos
|
||
P, Misiorowski
|
||
W
|
||
et al. Cinacalcet normalizes serum calcium in a double-blind randomized, placebo-controlled study in patients with primary hyperparathyroidism with contraindications to surgery. European Journal of Endocrinology. 2015; 172(5):527–35 [<a href="/pmc/articles/PMC5729741/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC5729741</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/25637076" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 25637076</span></a>]</div></dd><dt>13.</dt><dd><div class="bk_ref" id="ch8.ref13">Khan
|
||
AA, Bilezikian
|
||
JP, Bone
|
||
HG, Gurevich
|
||
A, Lakatos
|
||
P, Misiorowski
|
||
W
|
||
et al. Cinacalcet normalizes serum calcium in a randomized, placebocontrolled clinical study in patients with primary hyperparathyroidism unable to undergo parathyroidectomy. Endocrine Reviews. 2014; 35:(4 Suppl):MON–0196</div></dd><dt>14.</dt><dd><div class="bk_ref" id="ch8.ref14">Khan
|
||
AA, Bilezikian
|
||
JP, Kung
|
||
A, Dubois
|
||
SJ, Standish
|
||
TI, Syed
|
||
ZA. Alendronate therapy in men with primary hyperparathyroidism. Endocrine Practice. 2009; 15(7):705–13 [<a href="/pmc/articles/PMC4357232/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC4357232</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/19625240" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 19625240</span></a>]</div></dd><dt>15.</dt><dd><div class="bk_ref" id="ch8.ref15">Khan
|
||
AA, Bilezikian
|
||
JP, Kung
|
||
AW, Ahmed
|
||
MM, Dubois
|
||
SJ, Ho
|
||
AY
|
||
et al. Alendronate in primary hyperparathyroidism: a double-blind, randomized, placebo-controlled trial. Journal of Clinical Endocrinology and Metabolism. 2004; 89(7):3319–25 [<a href="https://pubmed.ncbi.nlm.nih.gov/15240609" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 15240609</span></a>]</div></dd><dt>16.</dt><dd><div class="bk_ref" id="ch8.ref16">Martin
|
||
M, Robbins
|
||
S, Lu
|
||
ZJ. Use of cinacalcet in patients with intractable primary hyperparathyroidism (PHPT): A UK budget impact analysis. Endocrine Abstracts. 2010; 20:P228</div></dd><dt>17.</dt><dd><div class="bk_ref" id="ch8.ref17">Narayan
|
||
R, Perkins
|
||
RM, Berbano
|
||
EP, Yuan
|
||
CM, Neff
|
||
RT, Sawyers
|
||
ES
|
||
et al. Parathyroidectomy versus cinacalcet hydrochloride-based medical therapy in the management of hyperparathyroidism in ESRD: a cost utility analysis. American Journal of Kidney Diseases. 2007; 49(6):801–13 [<a href="https://pubmed.ncbi.nlm.nih.gov/17533023" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 17533023</span></a>]</div></dd><dt>18.</dt><dd><div class="bk_ref" id="ch8.ref18">National Institute for Health and Care Excellence. Developing NICE guidelines: the manual. London. National Institute for Health and Care Excellence, 2014. Available from: <a href="http://www.nice.org.uk/article/PMG20/chapter/1%20Introduction%20and%20overview" ref="pagearea=cite-ref&targetsite=external&targetcat=link&targettype=uri">http://www<wbr style="display:inline-block"></wbr>.nice.org.uk<wbr style="display:inline-block"></wbr>/article/PMG20/chapter<wbr style="display:inline-block"></wbr>/1%20Introduction%20and%20overview</a> [<a href="https://pubmed.ncbi.nlm.nih.gov/26677490" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 26677490</span></a>]</div></dd><dt>19.</dt><dd><div class="bk_ref" id="ch8.ref19">NHS Business Services Authority. NHS electronic drug tariff September 2017. Available from: <a href="https://www.nhsbsa.nhs.uk/pharmacies-gp-practices-and-appliance-contractors/drug-tariff" ref="pagearea=cite-ref&targetsite=external&targetcat=link&targettype=uri">https://www<wbr style="display:inline-block"></wbr>.nhsbsa.nhs<wbr style="display:inline-block"></wbr>.uk/pharmacies-gp-practices-and-appliance-contractors<wbr style="display:inline-block"></wbr>/drug-tariff</a> Last accessed: 18/09/18.</div></dd><dt>20.</dt><dd><div class="bk_ref" id="ch8.ref20">Parker
|
||
CR, Blackwell
|
||
PJ, Fairbairn
|
||
KJ, Hosking
|
||
DJ. Alendronate in the treatment of primary hyperparathyroid-related osteoporosis: A 2-year study. Journal of Clinical Endocrinology and Metabolism. 2002; 87(10):4482–9 [<a href="https://pubmed.ncbi.nlm.nih.gov/12364423" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 12364423</span></a>]</div></dd><dt>21.</dt><dd><div class="bk_ref" id="ch8.ref21">Peacock
|
||
M, Bilezikian
|
||
JP, Bolognese
|
||
MA, Borofsky
|
||
M, Scumpia
|
||
S, Sterling
|
||
LR
|
||
et al. Cinacalcet HCl reduces hypercalcemia in primary hyperparathyroidism across a wide spectrum of disease severity. Journal of Clinical Endocrinology and Metabolism. 2011; 96(1):E9–18 [<a href="/pmc/articles/PMC3203649/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC3203649</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/20943783" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 20943783</span></a>]</div></dd><dt>22.</dt><dd><div class="bk_ref" id="ch8.ref22">Peacock
|
||
M, Bilezikian
|
||
JP, Klassen
|
||
PS, Guo
|
||
MD, Turner
|
||
SA, Shoback
|
||
D. Cinacalcet hydrochloride maintains long-term normocalcemia in patients with primary hyperparathyroidism. Journal of Clinical Endocrinology and Metabolism. 2005; 90(1):135–41 [<a href="https://pubmed.ncbi.nlm.nih.gov/15522938" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 15522938</span></a>]</div></dd><dt>23.</dt><dd><div class="bk_ref" id="ch8.ref23">Peacock
|
||
M, Bolognese
|
||
MA, Borofsky
|
||
M, Scumpia
|
||
S, Sterling
|
||
LR, Cheng
|
||
S
|
||
et al. Cinacalcet treatment of primary hyperparathyroidism: biochemical and bone densitometric outcomes in a five-year study. Journal of Clinical Endocrinology and Metabolism. 2009; 94(12):4860–7 [<a href="https://pubmed.ncbi.nlm.nih.gov/19837909" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 19837909</span></a>]</div></dd><dt>24.</dt><dd><div class="bk_ref" id="ch8.ref24">Reasner
|
||
CA, Stone
|
||
MD, Hosking
|
||
DJ, Ballah
|
||
A, Mundy
|
||
GR. Acute changes in calcium homeostasis during treatment of primary hyperparathyroidism with risedronate. Journal of Clinical Endocrinology and Metabolism. 1993; 77(4):1067–71 [<a href="https://pubmed.ncbi.nlm.nih.gov/8408454" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 8408454</span></a>]</div></dd><dt>25.</dt><dd><div class="bk_ref" id="ch8.ref25">Rossini
|
||
M, Gatti
|
||
D, Isaia
|
||
G, Sartori
|
||
L, Braga
|
||
V, Adami
|
||
S. Effects of oral alendronate in elderly patients with osteoporosis and mild primary hyperparathyroidism. Journal of Bone and Mineral Research. 2001; 16(1):113–9 [<a href="https://pubmed.ncbi.nlm.nih.gov/11149474" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 11149474</span></a>]</div></dd><dt>26.</dt><dd><div class="bk_ref" id="ch8.ref26">Sankaran
|
||
S, Gamble
|
||
G, Bolland
|
||
M, Reid
|
||
IR, Grey
|
||
A. Skeletal effects of interventions in mild primary hyperparathyroidism: A meta-analysis. Journal of Clinical Endocrinology and Metabolism. 2010; 95(4):1653–62 [<a href="https://pubmed.ncbi.nlm.nih.gov/20130069" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 20130069</span></a>]</div></dd><dt>27.</dt><dd><div class="bk_ref" id="ch8.ref27">Schwarz
|
||
P, Body
|
||
JJ, Cap
|
||
J, Hofbauer
|
||
LC, Farouk
|
||
M, Gessl
|
||
A
|
||
et al. The PRIMARA study: a prospective, descriptive, observational study to review cinacalcet use in patients with primary hyperparathyroidism in clinical practice. European Journal of Endocrinology. 2014; 171(6):727–35 [<a href="https://pubmed.ncbi.nlm.nih.gov/25240499" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 25240499</span></a>]</div></dd><dt>28.</dt><dd><div class="bk_ref" id="ch8.ref28">Shoback
|
||
DM, Bilezikian
|
||
JP, Turner
|
||
SA, McCary
|
||
LC, Guo
|
||
MD, Peacock
|
||
M. The calcimimetic cinacalcet normalizes serum calcium in subjects with primary hyperparathyroidism. Journal of Clinical Endocrinology and Metabolism. 2003; 88(12):5644–9 [<a href="https://pubmed.ncbi.nlm.nih.gov/14671147" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 14671147</span></a>]</div></dd><dt>29.</dt><dd><div class="bk_ref" id="ch8.ref29">Szczech
|
||
LA. The impact of calcimimetic agents on the use of different classes of phosphate binders: Results of recent clinical trials. Kidney International, Supplement. 2004; 66(90):S46–S48 [<a href="https://pubmed.ncbi.nlm.nih.gov/15296507" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 15296507</span></a>]</div></dd></dl></div><div id="appendixesappgroup8"><h2 id="_appendixesappgroup8_">Appendices</h2><div id="ch8.appa"><h3>Appendix A. Review protocols</h3><div id="ch8.appa.tab1" class="table"><h3><span class="label">Table 6</span><span class="title">Review protocol: Bisphosphonates</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK577895/table/ch8.appa.tab1/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__ch8.appa.tab1_lrgtbl__"><table><thead><tr><th id="hd_h_ch8.appa.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Field</th><th id="hd_h_ch8.appa.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Content</th></tr></thead><tbody><tr><td headers="hd_h_ch8.appa.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Review question</td><td headers="hd_h_ch8.appa.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">What is the clinical and cost effectiveness of bisphosphonates in people with primary hyperparathyroidism?</td></tr><tr><td headers="hd_h_ch8.appa.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Type of review question</td><td headers="hd_h_ch8.appa.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
||
<p>Intervention</p>
|
||
<p>A review of health economic evidence related to the same review question was conducted in parallel with this review. For details see the health economic review protocol for this NICE guideline.</p>
|
||
</td></tr><tr><td headers="hd_h_ch8.appa.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Objective of the review</td><td headers="hd_h_ch8.appa.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">To assess the effectiveness of bisphosphonates for treatment of people with primary hyperparathyroidism</td></tr><tr><td headers="hd_h_ch8.appa.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Eligibility criteria – population</td><td headers="hd_h_ch8.appa.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
||
<p>Adults (18 years or over) with confirmed primary hyperparathyroidism</p>
|
||
<p>Strata (report the following groups separately):
|
||
<ul id="ch8.l2"><li id="ch8.lt5" class="half_rhythm"><div>Absence/presence of bone end-organ effects (bone end-organ effects defined as history of fragility fractures or osteoporosis (BMD T-score <−2.5 at any site)</div></li><li id="ch8.lt6" class="half_rhythm"><div>People with normocalcaemic PHPT (serum adjusted calcium ≤2.6 mmol/L and an elevated PTH that cannot be explained by abnormal renal function or low 25OHD)</div></li><li id="ch8.lt7" class="half_rhythm"><div>Previous parathyroidectomy</div></li><li id="ch8.lt8" class="half_rhythm"><div>Pregnant women</div></li></ul>
|
||
Exclude people:
|
||
<ul id="ch8.l3"><li id="ch8.lt9" class="half_rhythm"><div>with secondary and tertiary HPT</div></li><li id="ch8.lt10" class="half_rhythm"><div>with multiple endocrine neoplasia (MEN)</div></li><li id="ch8.lt11" class="half_rhythm"><div>with familial hyperparathyroidism</div></li><li id="ch8.lt12" class="half_rhythm"><div>with parathyroid carcinoma</div></li><li id="ch8.lt13" class="half_rhythm"><div>on medications interfering with calcium metabolism (for example, lithium).</div></li></ul>
|
||
Studies including mixed populations of people with primary and secondary or tertiary hyperparathyroidism will be excluded unless subgroups reported separately by type of hyperparathyroidism.</p>
|
||
</td></tr><tr><td headers="hd_h_ch8.appa.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Eligibility criteria – intervention(s)</td><td headers="hd_h_ch8.appa.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
||
<ul id="ch8.l4"><li id="ch8.lt14" class="half_rhythm"><div>Oral bisphosphonates (alendronic acid/alendronate, ibandronic acid, risedronate/ risedronate sodium, sodium clodronate, etidronate)</div></li><li id="ch8.lt15" class="half_rhythm"><div>IV bisphosphonates (ibandronic acid, pamidronate disodium, zoledronic acid)</div></li></ul>
|
||
</td></tr><tr><td headers="hd_h_ch8.appa.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Eligibility criteria – comparator(s)</td><td headers="hd_h_ch8.appa.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
||
<ul id="ch8.l5"><li id="ch8.lt16" class="half_rhythm"><div>Placebo</div></li><li id="ch8.lt17" class="half_rhythm"><div>No treatment (surveillance/conservative management)</div></li><li id="ch8.lt18" class="half_rhythm"><div>Surgery (see protocol in <a href="/books/n/niceng132er3/" class="toc-item">evidence report C</a>)</div></li><li id="ch8.lt19" class="half_rhythm"><div>Calcimimetics (see protocol in <a href="/books/n/niceng132er7/" class="toc-item">evidence report G</a>)</div></li><li id="ch8.lt20" class="half_rhythm"><div>Combination treatment (calcimimetics and bisphosphonates)</div></li></ul>
|
||
The above comparators will not be pooled in the analysis</td></tr><tr><td headers="hd_h_ch8.appa.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Outcomes and prioritisation</td><td headers="hd_h_ch8.appa.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
||
<p>Report all outcomes separately for <6 months and ≥6 months (for fractures and BMD only report outcomes ≥12 months)</p>
|
||
<p><b>Critical outcomes:</b>
|
||
<ul id="ch8.l6"><li id="ch8.lt21" class="half_rhythm"><div>HRQOL (continuous outcome)</div></li><li id="ch8.lt22" class="half_rhythm"><div>Mortality (dichotomous outcome)</div></li></ul>
|
||
<b>Important outcomes:</b>
|
||
<ul id="ch8.l7"><li id="ch8.lt23" class="half_rhythm"><div>Deterioration in renal function (dichotomous – study may also report renal replacement)</div></li><li id="ch8.lt24" class="half_rhythm"><div>Fractures (vertebral or long bone) (dichotomous outcome)</div></li><li id="ch8.lt25" class="half_rhythm"><div>Occurrence of kidney stones (dichotomous outcome)</div></li><li id="ch8.lt26" class="half_rhythm"><div>Persistent hypercalcaemia (dichotomous outcome)</div></li><li id="ch8.lt27" class="half_rhythm"><div>BMD (continuous) of the distal radius or the lumbar spine</div></li><li id="ch8.lt28" class="half_rhythm"><div>Cardiovascular events (dichotomous outcome)</div></li><li id="ch8.lt29" class="half_rhythm"><div>Adverse events (to include discontinuation due to side effects; dichotomous outcome)</div></li><li id="ch8.lt30" class="half_rhythm"><div>Cancer incidence (dichotomous outcome)</div></li></ul></p>
|
||
</td></tr><tr><td headers="hd_h_ch8.appa.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Eligibility criteria – study design</td><td headers="hd_h_ch8.appa.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
||
<p>RCTs and systematic reviews of RCTs</p>
|
||
<p>In the absence of RCT evidence NRSs will be included (only if the following key confounders are matched for or adjusted for in the analysis)</p>
|
||
<p>Key confounders:
|
||
<ul id="ch8.l8"><li id="ch8.lt31" class="half_rhythm"><div>Age</div></li><li id="ch8.lt32" class="half_rhythm"><div>Absence/presence of end-organ effects</div></li><li id="ch8.lt33" class="half_rhythm"><div>Adjusted serum calcium level</div></li></ul></p>
|
||
</td></tr><tr><td headers="hd_h_ch8.appa.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Other inclusion exclusion criteria</td><td headers="hd_h_ch8.appa.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
||
<ul id="ch8.l9"><li id="ch8.lt34" class="half_rhythm"><div>Non-English language articles</div></li><li id="ch8.lt35" class="half_rhythm"><div>Conference abstracts</div></li></ul></td></tr><tr><td headers="hd_h_ch8.appa.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Proposed sensitivity / subgroup analysis, or meta-regression</td><td headers="hd_h_ch8.appa.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
||
<p>IV versus oral bisphosphonates</p>
|
||
<p>Sensitivity analysis: if there is still heterogeneity in the data following subgroup analysis, remove any studies from the analysis that use the Z-score to recruit people with a low BMD, rather than the T-score to recruit people with osteoporosis.</p>
|
||
</td></tr><tr><td headers="hd_h_ch8.appa.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Selection process – duplicate screening / selection / analysis</td><td headers="hd_h_ch8.appa.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Studies are sifted by title and abstract. Potentially significant publications obtained in full text are then assessed against the inclusion criteria specified in this protocol.</td></tr><tr><td headers="hd_h_ch8.appa.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Data management (software)</td><td headers="hd_h_ch8.appa.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
||
<ul id="ch8.l10"><li id="ch8.lt36" class="half_rhythm"><div>Pairwise meta-analyses were performed using Cochrane Review Manager (RevMan5).</div></li><li id="ch8.lt37" class="half_rhythm"><div>GRADEpro was used to assess the quality of evidence for each outcome.</div></li><li id="ch8.lt38" class="half_rhythm"><div>Endnote for bibliography, citations, sifting and reference management Data extractions performed using EviBase, a platform designed and maintained by the National Guideline Centre (NGC)</div></li></ul></td></tr><tr><td headers="hd_h_ch8.appa.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Information sources – databases and dates</td><td headers="hd_h_ch8.appa.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
||
<p>Clinical search databases to be used: Medline, Embase, Cochrane Library, CINAHL, PsycINFO</p>
|
||
<p>Date: all years</p>
|
||
<p>Health economics search databases to be used: Medline, Embase, NHSEED, HTA</p>
|
||
<p>Date: Medline, Embase from 2002</p>
|
||
<p>NHSEED, HTA – all years</p>
|
||
<p>Language: Restrict to English only</p>
|
||
<p>Supplementary search techniques: backward citation searching</p>
|
||
<p>Key papers: Not known</p>
|
||
</td></tr><tr><td headers="hd_h_ch8.appa.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Identify if an update</td><td headers="hd_h_ch8.appa.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Not applicable</td></tr><tr><td headers="hd_h_ch8.appa.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Author contacts</td><td headers="hd_h_ch8.appa.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
||
<a href="https://www.nice.org.uk/guidance/indevelopment/gid-ng10051" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">https://www<wbr style="display:inline-block"></wbr>.nice.org<wbr style="display:inline-block"></wbr>.uk/guidance/indevelopment/gid-ng10051</a>
|
||
</td></tr><tr><td headers="hd_h_ch8.appa.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Highlight if amendment to previous protocol</td><td headers="hd_h_ch8.appa.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">For details please see section 4.5 of <a href="https://www.nice.org.uk/article/pmg20/chapter/4-Developing-review-questions-and-planning-the-evidence-review#planning-the-evidence-review" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">Developing NICE guidelines: the manual</a>.</td></tr><tr><td headers="hd_h_ch8.appa.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Search strategy – for one database</td><td headers="hd_h_ch8.appa.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">For details please see <a href="#ch8.appb">appendix B</a>.</td></tr><tr><td headers="hd_h_ch8.appa.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Data collection process – forms / duplicate</td><td headers="hd_h_ch8.appa.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">A standardised evidence table format will be used, and published as <a href="#ch8.appd">appendix D</a> of the evidence report.</td></tr><tr><td headers="hd_h_ch8.appa.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Data items – define all variables to be collected</td><td headers="hd_h_ch8.appa.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">For details please see evidence tables in <a href="#ch8.appd">Appendix D</a> (clinical evidence tables) or <a href="#ch8.apph">H</a> (health economic evidence tables).</td></tr><tr><td headers="hd_h_ch8.appa.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Methods for assessing bias at outcome / study level</td><td headers="hd_h_ch8.appa.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Standard study checklists were used to critically appraise individual studies. For details please see section 6.2 of <a href="https://www.nice.org.uk/article/pmg20/chapter/6-Reviewing-research-evidence#assessing-the-quality-of-the-evidence" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">Developing NICE guidelines: the manual</a>. The risk of bias across all available evidence was evaluated for each outcome using an adaptation of the ‘Grading of Recommendations Assessment, Development and Evaluation (GRADE) toolbox’ developed by the international GRADE working group <a href="http://www.gradeworkinggroup.org/" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">http://www<wbr style="display:inline-block"></wbr>.gradeworkinggroup.org/</a></td></tr><tr><td headers="hd_h_ch8.appa.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Criteria for quantitative synthesis</td><td headers="hd_h_ch8.appa.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">For details please see section 6.4 of <a href="https://www.nice.org.uk/article/pmg20/chapter/6-Reviewing-research-evidence#assessing-the-quality-of-the-evidence" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">Developing NICE guidelines: the manual</a>.</td></tr><tr><td headers="hd_h_ch8.appa.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Methods for quantitative analysis – combining studies and exploring (in)consistency</td><td headers="hd_h_ch8.appa.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">For details please see the separate Methods report for this guideline.</td></tr><tr><td headers="hd_h_ch8.appa.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Meta-bias assessment – publication bias, selective reporting bias</td><td headers="hd_h_ch8.appa.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">For details please see section 6.2 of <a href="https://www.nice.org.uk/article/pmg20/chapter/6-Reviewing-research-evidence#assessing-the-quality-of-the-evidence" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">Developing NICE guidelines: the manual</a>.</td></tr><tr><td headers="hd_h_ch8.appa.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Confidence in cumulative evidence</td><td headers="hd_h_ch8.appa.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">For details please see sections 6.4 and 9.1 of <a href="https://www.nice.org.uk/article/pmg20/chapter/1-Introduction-and-overview" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">Developing NICE guidelines: the manual</a>.</td></tr><tr><td headers="hd_h_ch8.appa.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Rationale / context – what is known</td><td headers="hd_h_ch8.appa.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">For details please see the introduction to the evidence review.</td></tr><tr><td headers="hd_h_ch8.appa.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Describe contributions of authors and guarantor</td><td headers="hd_h_ch8.appa.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
||
<p>A <a href="https://www.nice.org.uk/guidance/indevelopment/gid-ng10051" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">multidisciplinary committee</a> developed the evidence review. The committee was convened by the National Guideline Centre (NGC) and chaired by Jonathan Mant in line with section 3 of <a href="https://www.nice.org.uk/article/pmg20/chapter/1%20Introduction%20and%20overview" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">Developing NICE guidelines: the manual</a>.</p>
|
||
<p>Staff from the NGC undertook systematic literature searches, appraised the evidence, conducted meta-analysis and cost-effectiveness analysis where appropriate, and drafted the evidence review in collaboration with the committee. For details please see <a href="https://www.nice.org.uk/article/pmg20/chapter/1-Introduction-and-overview" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">Developing NICE guidelines: the manual</a>.</p>
|
||
</td></tr><tr><td headers="hd_h_ch8.appa.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Sources of funding / support</td><td headers="hd_h_ch8.appa.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">The NGC is funded by NICE and hosted by the Royal College of Physicians.</td></tr><tr><td headers="hd_h_ch8.appa.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Name of sponsor</td><td headers="hd_h_ch8.appa.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">The NGC is funded by NICE and hosted by the Royal College of Physicians.</td></tr><tr><td headers="hd_h_ch8.appa.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Roles of sponsor</td><td headers="hd_h_ch8.appa.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">NICE funds the NGC to develop guidelines for those working in the NHS, public health and social care in England.</td></tr><tr><td headers="hd_h_ch8.appa.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">PROSPERO registration number</td><td headers="hd_h_ch8.appa.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Not registered</td></tr></tbody></table></div></div><div id="ch8.appa.tab2" class="table"><h3><span class="label">Table 7</span><span class="title">Health economic review protocol</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK577895/table/ch8.appa.tab2/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__ch8.appa.tab2_lrgtbl__"><table><thead><tr><th id="hd_h_ch8.appa.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:middle;">Review question</th><th id="hd_h_ch8.appa.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:middle;">All questions – health economic evidence</th></tr></thead><tbody><tr><td headers="hd_h_ch8.appa.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
||
<b>Objectives</b>
|
||
</td><td headers="hd_h_ch8.appa.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">To identify health economic studies relevant to any of the review questions.</td></tr><tr><td headers="hd_h_ch8.appa.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
||
<b>Search criteria</b>
|
||
</td><td headers="hd_h_ch8.appa.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
||
|
||
<ul id="ch8.l11"><li id="ch8.lt39" class="half_rhythm"><div class="half_rhythm">Populations, interventions and comparators must be as specified in the clinical review protocol above.</div></li><li id="ch8.lt40" class="half_rhythm"><div class="half_rhythm">Studies must be of a relevant health economic study design (cost–utility analysis, cost-effectiveness analysis, cost–benefit analysis, cost–consequences analysis, comparative cost analysis).</div></li><li id="ch8.lt41" class="half_rhythm"><div class="half_rhythm">Studies must not be a letter, editorial or commentary, or a review of health economic evaluations (recent reviews will be ordered although not reviewed. The bibliographies will be checked for relevant studies, which will then be ordered).</div></li><li id="ch8.lt42" class="half_rhythm"><div class="half_rhythm">Unpublished reports will not be considered unless submitted as part of a call for evidence.</div><div class="half_rhythm">Studies must be in English.</div></li></ul>
|
||
</td></tr><tr><td headers="hd_h_ch8.appa.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
||
<b>Search strategy</b>
|
||
</td><td headers="hd_h_ch8.appa.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">A health economic study search will be undertaken using population-specific terms and a health economic study filter – see <a href="#ch8.appb">appendix B</a> below.</td></tr><tr><td headers="hd_h_ch8.appa.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
||
<b>Review strategy</b>
|
||
</td><td headers="hd_h_ch8.appa.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
||
<p>Studies not meeting any of the search criteria above will be excluded. Studies published before 2002, abstract-only studies and studies from non-OECD countries or the USA will also be excluded.</p>
|
||
<p>Each remaining study will be assessed for applicability and methodological limitations using the NICE economic evaluation checklist which can be found in <a href="#ch8.apph">appendix H</a> of Developing NICE guidelines: the manual (2014).<a class="bk_pop" href="#ch8.ref18"><sup>18</sup></a></p>
|
||
<p><b>Inclusion and exclusion criteria</b>
|
||
<ul id="ch8.l12"><li id="ch8.lt43" class="half_rhythm"><div>If a study is rated as both ‘Directly applicable’ and with ‘Minor limitations’ then it will be included in the guideline. A health economic evidence table will be completed and it will be included in the health economic evidence profile.</div></li><li id="ch8.lt44" class="half_rhythm"><div>If a study is rated as either ‘Not applicable’ or with ‘Very serious limitations’ then it will usually be excluded from the guideline. If it is excluded then a health economic evidence table will not be completed and it will not be included in the health economic evidence profile.</div></li><li id="ch8.lt45" class="half_rhythm"><div>If a study is rated as ‘Partially applicable’, with ‘Potentially serious limitations’ or both then there is discretion over whether it should be included.</div></li></ul>
|
||
<b>Where there is discretion</b></p>
|
||
<p>The health economist will make a decision based on the relative applicability and quality of the available evidence for that question, in discussion with the guideline committee if required. The ultimate aim is to include health economic studies that are helpful for decision-making in the context of the guideline and the current NHS setting. If several studies are considered of sufficiently high applicability and methodological quality that they could all be included, then the health economist, in discussion with the committee if required, may decide to include only the most applicable studies and to selectively exclude the remaining studies. All studies excluded on the basis of applicability or methodological limitations will be listed with explanation in the excluded health economic studies appendix below.</p>
|
||
<p>The health economist will be guided by the following hierarchies.</p>
|
||
<p><i>Setting:</i>
|
||
<ul id="ch8.l13"><li id="ch8.lt46" class="half_rhythm"><div>UK NHS (most applicable).</div></li><li id="ch8.lt47" class="half_rhythm"><div>OECD countries with predominantly public health insurance systems (for example, France, Germany, Sweden).</div></li><li id="ch8.lt48" class="half_rhythm"><div>OECD countries with predominantly private health insurance systems (for example, Switzerland).</div></li><li id="ch8.lt49" class="half_rhythm"><div>Studies set in non-OECD countries or in the USA will be excluded before being assessed for applicability and methodological limitations.</div></li></ul>
|
||
<i>Health economic study type:</i>
|
||
<ul id="ch8.l14"><li id="ch8.lt50" class="half_rhythm"><div>Cost–utility analysis (most applicable).</div></li><li id="ch8.lt51" class="half_rhythm"><div>Other type of full economic evaluation (cost–benefit analysis, cost-effectiveness analysis, cost–consequences analysis).</div></li><li id="ch8.lt52" class="half_rhythm"><div>Comparative cost analysis.</div></li><li id="ch8.lt53" class="half_rhythm"><div>Non-comparative cost analyses including cost-of-illness studies will be excluded before being assessed for applicability and methodological limitations.</div></li></ul>
|
||
<i>Year of analysis:</i>
|
||
<ul id="ch8.l15"><li id="ch8.lt54" class="half_rhythm"><div>The more recent the study, the more applicable it will be.</div></li><li id="ch8.lt55" class="half_rhythm"><div>Studies published in 2002 or later but that depend on unit costs and resource data entirely or predominantly from before 2002 will be rated as ‘Not applicable’.</div></li><li id="ch8.lt56" class="half_rhythm"><div>Studies published before 2002 will be excluded before being assessed for applicability and methodological limitations.</div></li></ul>
|
||
<i>Quality and relevance of effectiveness data used in the health economic analysis:</i>
|
||
<ul id="ch8.l16"><li id="ch8.lt57" class="half_rhythm"><div>The more closely the clinical effectiveness data used in the health economic analysis match with the outcomes of the studies included in the clinical review the more useful the analysis will be for decision-making in the guideline.</div></li></ul></p>
|
||
</td></tr></tbody></table></div></div></div><div id="ch8.appb"><h3>Appendix B. Literature search strategies</h3><p>The literature searches for this review are detailed below and complied with the methodology outlined in Developing NICE guidelines: the manual 2014, updated 2017 <a href="https://www.nice.org.uk/guidance/pmg20/resources/developing-nice-guidelines-the-manual-pdf-72286708700869" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">https://www.nice.org.uk/guidance/pmg20/resources/developing-nice-guidelines-the-manual-pdf-72286708700869</a></p><p><i>For more detailed information, please see the</i> Methodology <i>Review</i>.</p><div id="ch8.appb.s1"><h4>B.1. Clinical search literature search strategy</h4><p>Searches were constructed using a PICO framework where population (P) terms were combined with Intervention (I) and in some cases Comparison (C) terms. Outcomes (O) are rarely used in search strategies for interventions as these concepts may not be well described in title, abstract or indexes and are therefore difficult to retrieve. Search filters were applied to the search where appropriate.</p><div id="ch8.appb.tab1" class="table"><h3><span class="label">Table 8</span><span class="title">Database date parameters and filters used</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK577895/table/ch8.appb.tab1/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__ch8.appb.tab1_lrgtbl__"><table><thead><tr><th id="hd_h_ch8.appb.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Database</th><th id="hd_h_ch8.appb.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Dates searched</th><th id="hd_h_ch8.appb.tab1_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Search filter used</th></tr></thead><tbody><tr><td headers="hd_h_ch8.appb.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Medline (OVID)</td><td headers="hd_h_ch8.appb.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">1946 – 06 August 2018</td><td headers="hd_h_ch8.appb.tab1_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Exclusions</td></tr><tr><td headers="hd_h_ch8.appb.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Embase (OVID)</td><td headers="hd_h_ch8.appb.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">1974 – 06 August 2018</td><td headers="hd_h_ch8.appb.tab1_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Exclusions</td></tr><tr><td headers="hd_h_ch8.appb.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">The Cochrane Library (Wiley)</td><td headers="hd_h_ch8.appb.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
||
<p>Cochrane Reviews to 2018</p>
|
||
<p>Issue 8 of 12</p>
|
||
<p>CENTRAL to 2018 Issue 7 of 12</p>
|
||
<p>DARE, and NHSEED to 2015</p>
|
||
<p>Issue 2 of 4</p>
|
||
<p>HTA to 2016 Issue 4 of 4</p>
|
||
</td><td headers="hd_h_ch8.appb.tab1_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">None</td></tr><tr><td headers="hd_h_ch8.appb.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">CINAHL, Current Nursing and Allied Health Literature (EBSCO)</td><td headers="hd_h_ch8.appb.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Inception – 06 August 2018</td><td headers="hd_h_ch8.appb.tab1_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Exclusions</td></tr><tr><td headers="hd_h_ch8.appb.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">PsycINFO (ProQuest)</td><td headers="hd_h_ch8.appb.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Inception – 06 August 2018</td><td headers="hd_h_ch8.appb.tab1_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Exclusions</td></tr></tbody></table></div></div><div id="ch8.appb.tab2" class="table"><h3><span class="title">Medline (Ovid) search terms</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK577895/table/ch8.appb.tab2/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__ch8.appb.tab2_lrgtbl__"><table><tbody><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">1.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">hyperparathyroidism/ or hyperparathyroidism, primary/</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">2.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">((primary or asymptomatic or symptomatic or mild or familial or maternal) adj6 (HPT or hyperparathyroidis*)).ti,ab.</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">3.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">PHPT.ti,ab.</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">4.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Parathyroid Neoplasms/</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">5.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">(parathyroid* adj3 (adenoma* or carcinoma* or hyperplasia* or neoplas* or tumo?r* or cancer* or metasta* or hypercalc?emi*)).ti,ab.</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">6.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">or/1-5</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">7.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">letter/</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">8.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">editorial/</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">9.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">news/</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">10.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">exp historical article/</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">11.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Anecdotes as Topic/</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">12.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">comment/</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">13.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">case report/</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">14.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">(letter or comment*).ti.</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">15.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">or/7-14</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">16.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">randomized controlled trial/ or random*.ti,ab.</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">17.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">15 not 16</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">18.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">animals/ not humans/</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">19.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">exp Animals, Laboratory/</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">20.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">exp Animal Experimentation/</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">21.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">exp Models, Animal/</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">22.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">exp Rodentia/</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">23.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">(rat or rats or mouse or mice).ti.</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">24.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">or/17-23</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">25.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">6 not 24</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">26.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">limit 25 to English language</td></tr></tbody></table></div></div><div id="ch8.appb.tab3" class="table"><h3><span class="title">Embase (Ovid) search terms</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK577895/table/ch8.appb.tab3/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__ch8.appb.tab3_lrgtbl__"><table><tbody><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">1.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">hyperparathyroidism/ or primary hyperparathyroidism/</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">2.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">((primary or asymptomatic or symptomatic or mild or familial or maternal) adj6 (HPT or hyperparathyroidis*)).ti,ab.</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">3.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">PHPT.ti,ab.</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">4.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">parathyroid tumor/ or parathyroid adenoma/ or parathyroid carcinoma/</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">5.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">(parathyroid* adj3 (adenoma* or carcinoma* or hyperplasia* or neoplas* or tumo?r* or cancer* or metasta* or hypercalc?emi*)).ti,ab.</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">6.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">or/1-5</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">7.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">letter.pt. or letter/</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">8.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">note.pt.</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">9.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">editorial.pt.</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">10.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Case report/ or Case study/</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">11.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">(letter or comment*).ti.</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">12.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">or/7-11</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">13.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">randomized controlled trial/ or random*.ti,ab.</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">14.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">12 not 13</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">15.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">animal/ not human/</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">16.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Nonhuman/</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">17.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">exp Animal Experiment/</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">18.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">exp Experimental animal/</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">19.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Animal model/</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">20.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">exp Rodent/</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">21.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">(rat or rats or mouse or mice).ti.</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">22.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">or/14-21</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">23.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">6 not 22</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">24.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">limit 23 to English language</td></tr></tbody></table></div></div><div id="ch8.appb.tab4" class="table"><h3><span class="title">Cochrane Library (Wiley) search terms</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK577895/table/ch8.appb.tab4/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__ch8.appb.tab4_lrgtbl__"><table><tbody><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">#1.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">MeSH descriptor: [Hyperparathyroidism] explode all trees</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">#2.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">MeSH descriptor: [Hyperparathyroidism, Primary] explode all trees</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">#3.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">((primary or asymptomatic or symptomatic or mild or familial or maternal) near/6 (HPT or hyperparathyroidis*)):ti,ab</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">#4.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">PHPT:ti,ab</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">#5.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">MeSH descriptor: [Parathyroid Neoplasms] explode all trees</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">#6.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">(parathyroid* near/3 (adenoma* or carcinoma* or hyperplasia* or neoplas* or tumo?r* or cancer* or metasta* or hypercalc?emi*)):ti,ab</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">#7.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">(or #1-#6)</td></tr></tbody></table></div></div><div id="ch8.appb.tab5" class="table"><h3><span class="title">CINAHL (EBSCO) search terms</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK577895/table/ch8.appb.tab5/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__ch8.appb.tab5_lrgtbl__"><table><tbody><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">S1.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">(MH “Hyperparathyroidism”)</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">S2.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">((primary or asymptomatic or symptomatic or mild or familial or maternal) n6 HPT) OR ((primary or asymptomatic or symptomatic or mild or familial or maternal) n6 hyperparathyroidis*)</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">S3.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">PHPT</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">S4.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">(MH “Parathyroid Neoplasms”)</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">S5.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">(parathyroid* n3 (adenoma* or carcinoma* or hyperplasia* or neoplas* or tumor* or tumour* or cancer* or metasta* or hypercalcemi* or hypercalcaemi*))</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">S6.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">S1 OR S2 OR S3 OR S4 OR S5</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">S7.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">PT anecdote or PT audiovisual or PT bibliography or PT biography or PT book or PT book review or PT brief item or PT cartoon or PT commentary or PT computer program or PT editorial or PT games or PT glossary or PT historical material or PT interview or PT letter or PT listservs or PT masters thesis or PT obituary or PT pamphlet or PT pamphlet chapter or PT pictorial or PT poetry or PT proceedings or PT “questions and answers” or PT response or PT software or PT teaching materials or PT website</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">S8.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">S6 NOT S7</td></tr></tbody></table></div></div><div id="ch8.appb.tab6" class="table"><h3><span class="title">PsycINFO (ProQuest) search terms</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK577895/table/ch8.appb.tab6/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__ch8.appb.tab6_lrgtbl__"><table><tbody><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">1.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">su.Exact(“parathyroid neoplasms” OR “hyperparathyroidism” OR “hyperparathyroidism, primary”)</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">2.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">PHPT</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">3.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">((primary or asymptomatic or symptomatic or mild or familial or maternal) Near/6 (HPT or hyperparathyroidis*))</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">4.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">(parathyroid* near/3 (adenoma* or carcinoma* or hyperplasia* or neoplas* or tumor* or tumour* or cancer* or metasta* or hypercalcaemi* or hypercalcemi*))</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">5.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">1 or 2 or 3 or 4</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">6.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">(su.exact.explode(“rodents”) or su.exact.explode(“mice”) or (su.exact(“animals”) not (su.exact(“human males”) or su.exact(“human females”))) or ti(rat or rats or mouse or mice))</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">7.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">(s1 or s2 or s3 or s4) NOT (su.exact.explode(“rodents”) or su.exact.explode(“mice”) or (su.exact(“animals”) not (su.exact(“human males”) or su.exact(“human females”))) or ti(rat or rats or mouse or mice))</td></tr></tbody></table></div></div></div><div id="ch8.appb.s2"><h4>B.2. Health Economics literature search strategy</h4><p>Health economic evidence was identified by conducting a broad search relating to primary hyperparathyroidism population in the NHS Economic Evaluation Database (NHS EED – this ceased to be updated after March 2015) and the Health Technology Assessment database (HTA) with no date restrictions. The NHS EED and HTA databases are hosted by the Centre for Research and Dissemination (CRD). Additional searches were run on Medline and Embase for health economics papers published since 2002.</p><div id="ch8.appb.tab7" class="table"><h3><span class="label">Table 9</span><span class="title">Database date parameters and filters used</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK577895/table/ch8.appb.tab7/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__ch8.appb.tab7_lrgtbl__"><table><thead><tr><th id="hd_h_ch8.appb.tab7_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Database</th><th id="hd_h_ch8.appb.tab7_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Dates searched</th><th id="hd_h_ch8.appb.tab7_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Search filter used</th></tr></thead><tbody><tr><td headers="hd_h_ch8.appb.tab7_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Medline</td><td headers="hd_h_ch8.appb.tab7_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">2002 – 06 August 2018</td><td headers="hd_h_ch8.appb.tab7_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
||
<p>Exclusions</p>
|
||
<p>Health economics studies</p>
|
||
</td></tr><tr><td headers="hd_h_ch8.appb.tab7_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Embase</td><td headers="hd_h_ch8.appb.tab7_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">2002 – 06 August 2018</td><td headers="hd_h_ch8.appb.tab7_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
||
<p>Exclusions</p>
|
||
<p>Health economics studies</p>
|
||
</td></tr><tr><td headers="hd_h_ch8.appb.tab7_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Centre for Research and Dissemination (CRD)</td><td headers="hd_h_ch8.appb.tab7_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
||
<p>HTA - Inception – 06 August 2018</p>
|
||
<p>NHSEED - Inception to March 2015</p>
|
||
</td><td headers="hd_h_ch8.appb.tab7_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">None</td></tr></tbody></table></div></div><div id="ch8.appb.tab8" class="table"><h3><span class="title">Medline (Ovid) search terms</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK577895/table/ch8.appb.tab8/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__ch8.appb.tab8_lrgtbl__"><table><tbody><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">1.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">hyperparathyroidism/ or hyperparathyroidism, primary/</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">2.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">((primary or asymptomatic or symptomatic or mild or familial or maternal) adj6 (HPT or hyperparathyroidis*)).ti,ab.</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">3.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">PHPT.ti,ab.</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">4.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Parathyroid Neoplasms/</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">5.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">(parathyroid* adj3 (adenoma* or carcinoma* or hyperplasia* or neoplas* or tumo?r* or cancer* or metasta* or hypercalc?emi*)).ti,ab.</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">6.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">or/1-5</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">7.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">letter/</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">8.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">editorial/</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">9.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">news/</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">10.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">exp historical article/</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">11.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Anecdotes as Topic/</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">12.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">comment/</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">13.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">case report/</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">14.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">(letter or comment*).ti.</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">15.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">or/7-14</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">16.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">randomized controlled trial/ or random*.ti,ab.</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">17.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">15 not 16</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">18.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">animals/ not humans/</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">19.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">exp Animals, Laboratory/</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">20.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">exp Animal Experimentation/</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">21.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">exp Models, Animal/</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">22.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">exp Rodentia/</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">23.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">(rat or rats or mouse or mice).ti.</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">24.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">or/17-23</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">25.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">6 not 24</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">26.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">limit 25 to English language</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">27.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Economics/</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">28.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Value of life/</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">29.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">exp “Costs and Cost Analysis”/</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">30.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">exp Economics, Hospital/</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">31.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">exp Economics, Medical/</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">32.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Economics, Nursing/</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">33.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Economics, Pharmaceutical/</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">34.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">exp “Fees and Charges”/</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">35.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">exp Budgets/</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">36.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">budget*.ti,ab.</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">37.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">cost*.ti.</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">38.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">(economic* or pharmaco?economic*).ti.</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">39.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">(price* or pricing*).ti,ab.</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">40.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">(cost* adj2 (effective* or utilit* or benefit* or minimi* or unit* or estimat* or variable*)).ab.</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">41.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">(financ* or fee or fees).ti,ab.</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">42.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">(value adj2 (money or monetary)).ti,ab.</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">43.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">or/27-42</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">44.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">26 and 43</td></tr></tbody></table></div></div><div id="ch8.appb.tab9" class="table"><h3><span class="title">Embase (Ovid) search terms</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK577895/table/ch8.appb.tab9/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__ch8.appb.tab9_lrgtbl__"><table><tbody><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">1.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">hyperparathyroidism/ or primary hyperparathyroidism/</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">2.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">((primary or asymptomatic or symptomatic or mild or familial or maternal) adj6 (HPT or hyperparathyroidis*)).ti,ab.</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">3.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">PHPT.ti,ab.</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">4.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">parathyroid tumor/ or parathyroid adenoma/ or parathyroid carcinoma/</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">5.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">(parathyroid* adj3 (adenoma* or carcinoma* or hyperplasia* or neoplas* or tumo?r* or cancer* or metasta* or hypercalc?emi*)).ti,ab.</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">6.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">or/1-5</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">7.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">letter.pt. or letter/</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">8.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">note.pt.</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">9.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">editorial.pt.</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">10.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Case report/ or Case study/</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">11.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">(letter or comment*).ti.</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">12.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">or/7-11</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">13.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">randomized controlled trial/ or random*.ti,ab.</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">14.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">12 not 13</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">15.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">animal/ not human/</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">16.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Nonhuman/</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">17.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">exp Animal Experiment/</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">18.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">exp Experimental animal/</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">19.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Animal model/</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">20.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">exp Rodent/</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">21.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">(rat or rats or mouse or mice).ti.</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">22.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">or/14-21</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">23.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">6 not 22</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">24.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">limit 23 to English language</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">25.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">health economics/</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">26.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">exp economic evaluation/</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">27.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">exp health care cost/</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">28.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">exp fee/</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">29.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">budget/</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">30.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">funding/</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">31.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">budget*.ti,ab.</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">32.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">cost*.ti.</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">33.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">(economic* or pharmaco?economic*).ti.</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">34.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">(price* or pricing*).ti,ab.</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">35.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">(cost* adj2 (effective* or utilit* or benefit* or minimi* or unit* or estimat* or variable*)).ab.</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">36.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">(financ* or fee or fees).ti,ab.</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">37.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">(value adj2 (money or monetary)).ti,ab.</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">38.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">or/25-37</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">39.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">24 and 38</td></tr></tbody></table></div></div><div id="ch8.appb.tab10" class="table"><h3><span class="title">NHS EED and HTA (CRD) search terms</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK577895/table/ch8.appb.tab10/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__ch8.appb.tab10_lrgtbl__"><table><tbody><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">#1.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">MeSH DESCRIPTOR Hyperparathyroidism EXPLODE ALL TREES</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">#2.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">MeSH DESCRIPTOR Hyperparathyroidism, Primary EXPLODE ALL TREES</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">#3.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">(((primary or asymptomatic or symptomatic or mild or familial or maternal) adj6 (HPT or hyperparathyroidis*)))</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">#4.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">(PHPT)</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">#5.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">MeSH DESCRIPTOR Parathyroid Neoplasms EXPLODE ALL TREES</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">#6.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">((parathyroid* adj3 (adenoma* or carcinoma* or hyperplasia* or neoplas* or tumo?r* or cancer* or metasta* or hypercalc?emi*)))</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">#7.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">#1 OR #2 OR #3 OR #4 OR #5 OR #6</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">#8.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">* IN NHSEED</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">#9.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">* IN HTA</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">#10.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">#7 AND #8</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">#11.</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">#7 AND #9</td></tr></tbody></table></div></div></div></div><div id="ch8.appc"><h3>Appendix C. Clinical evidence selection</h3><div id="ch8.appc.fig1" class="figure bk_fig"><div class="graphic"><a href="/core/lw/2.0/html/tileshop_pmc/tileshop_pmc_inline.html?title=Figure%201.%20Flow%20chart%20of%20clinical%20study%20selection%20for%20the%20review%20of%20pharmacological%20management%20(sifted%20for%20both%20calcimimetics%20and%20bisphosphonates%20reviews).&p=BOOKS&id=577895_ch8appcf1.jpg" target="tileshopwindow" class="inline_block pmc_inline_block ts_canvas img_link" title="Click on image to zoom"><div class="ts_bar small" title="Click on image to zoom"></div><img src="/books/NBK577895/bin/ch8appcf1.jpg" alt="Figure 1. Flow chart of clinical study selection for the review of pharmacological management (sifted for both calcimimetics and bisphosphonates reviews)." class="tileshop" title="Click on image to zoom" /></a></div><h3><span class="label">Figure 1</span><span class="title">Flow chart of clinical study selection for the review of pharmacological management (sifted for both calcimimetics and bisphosphonates reviews)</span></h3></div></div><div id="ch8.appd"><h3>Appendix D. Clinical evidence tables</h3><p id="ch8.appd.et1"><a href="/books/NBK577895/bin/ch8-appd-et1.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Download PDF</a><span class="small"> (192K)</span></p></div><div id="ch8.appe"><h3>Appendix E. Forest plots</h3><div id="ch8.appe.s1"><h4>E.1. People with normocalcaemic PHPT and presence of bone end-organ effects</h4><div id="ch8.appe.s1.1"><h5>E.1.1. Alendronate + Vitamin D versus Vitamin D only</h5><div id="ch8.appe.fig1" class="figure bk_fig"><div class="graphic"><a href="/core/lw/2.0/html/tileshop_pmc/tileshop_pmc_inline.html?title=Figure%202.%20Lumbar%20spine%20BMD%20(g%2Fcm2)%20at%2012%20months.&p=BOOKS&id=577895_ch8appef1.jpg" target="tileshopwindow" class="inline_block pmc_inline_block ts_canvas img_link" title="Click on image to zoom"><div class="ts_bar small" title="Click on image to zoom"></div><img src="/books/NBK577895/bin/ch8appef1.jpg" alt="Figure 2. Lumbar spine BMD (g/cm2) at 12 months." class="tileshop" title="Click on image to zoom" /></a></div><h3><span class="label">Figure 2</span><span class="title">Lumbar spine BMD (g/cm<sup>2</sup>) at 12 months</span></h3></div><div id="ch8.appe.fig2" class="figure bk_fig"><div class="graphic"><a href="/core/lw/2.0/html/tileshop_pmc/tileshop_pmc_inline.html?title=Figure%203.%20Incidence%20of%20hypercalcaemia%20or%20hypercalciuria%20in%2012%20months.&p=BOOKS&id=577895_ch8appef2.jpg" target="tileshopwindow" class="inline_block pmc_inline_block ts_canvas img_link" title="Click on image to zoom"><div class="ts_bar small" title="Click on image to zoom"></div><img src="/books/NBK577895/bin/ch8appef2.jpg" alt="Figure 3. Incidence of hypercalcaemia or hypercalciuria in 12 months." class="tileshop" title="Click on image to zoom" /></a></div><h3><span class="label">Figure 3</span><span class="title">Incidence of hypercalcaemia or hypercalciuria in 12 months</span></h3></div></div></div><div id="ch8.appe.s2"><h4>E.2. People with hypercalcaemic PHPT and presence of bone end-organ effects</h4><div id="ch8.appe.s2.1"><h5>E.2.1. Alendronate versus Placebo</h5><div id="ch8.appe.fig3" class="figure bk_fig"><div class="graphic"><a href="/core/lw/2.0/html/tileshop_pmc/tileshop_pmc_inline.html?title=Figure%204.%20Change%20in%20lumbar%20spine%20BMD%20(%25%20change%20from%20baseline)%20over%2048%20weeks.&p=BOOKS&id=577895_ch8appef3.jpg" target="tileshopwindow" class="inline_block pmc_inline_block ts_canvas img_link" title="Click on image to zoom"><div class="ts_bar small" title="Click on image to zoom"></div><img src="/books/NBK577895/bin/ch8appef3.jpg" alt="Figure 4. Change in lumbar spine BMD (% change from baseline) over 48 weeks." class="tileshop" title="Click on image to zoom" /></a></div><h3><span class="label">Figure 4</span><span class="title">Change in lumbar spine BMD (% change from baseline) over 48 weeks</span></h3></div><div id="ch8.appe.fig4" class="figure bk_fig"><div class="graphic"><a href="/core/lw/2.0/html/tileshop_pmc/tileshop_pmc_inline.html?title=Figure%205.%20Change%20in%20distal%20radius%20BMD%20(%25%20change%20from%20baseline)%20over%2048%20weeks.&p=BOOKS&id=577895_ch8appef4.jpg" target="tileshopwindow" class="inline_block pmc_inline_block ts_canvas img_link" title="Click on image to zoom"><div class="ts_bar small" title="Click on image to zoom"></div><img src="/books/NBK577895/bin/ch8appef4.jpg" alt="Figure 5. Change in distal radius BMD (% change from baseline) over 48 weeks." class="tileshop" title="Click on image to zoom" /></a></div><h3><span class="label">Figure 5</span><span class="title">Change in distal radius BMD (% change from baseline) over 48 weeks</span></h3></div><div id="ch8.appe.fig5" class="figure bk_fig"><div class="graphic"><a href="/core/lw/2.0/html/tileshop_pmc/tileshop_pmc_inline.html?title=Figure%206.%20Number%20of%20serious%20adverse%20events%20in%2048%20weeks.&p=BOOKS&id=577895_ch8appef5.jpg" target="tileshopwindow" class="inline_block pmc_inline_block ts_canvas img_link" title="Click on image to zoom"><div class="ts_bar small" title="Click on image to zoom"></div><img src="/books/NBK577895/bin/ch8appef5.jpg" alt="Figure 6. Number of serious adverse events in 48 weeks." class="tileshop" title="Click on image to zoom" /></a></div><h3><span class="label">Figure 6</span><span class="title">Number of serious adverse events in 48 weeks</span></h3></div><div id="ch8.appe.fig6" class="figure bk_fig"><div class="graphic"><a href="/core/lw/2.0/html/tileshop_pmc/tileshop_pmc_inline.html?title=Figure%207.%20Number%20of%20fractures%20in%2012%20months.&p=BOOKS&id=577895_ch8appef6.jpg" target="tileshopwindow" class="inline_block pmc_inline_block ts_canvas img_link" title="Click on image to zoom"><div class="ts_bar small" title="Click on image to zoom"></div><img src="/books/NBK577895/bin/ch8appef6.jpg" alt="Figure 7. Number of fractures in 12 months." class="tileshop" title="Click on image to zoom" /></a></div><h3><span class="label">Figure 7</span><span class="title">Number of fractures in 12 months</span></h3></div><div id="ch8.appe.fig7" class="figure bk_fig"><div class="graphic"><a href="/core/lw/2.0/html/tileshop_pmc/tileshop_pmc_inline.html?title=Figure%208.%20Number%20of%20adverse%20events%20in%2012%20months.&p=BOOKS&id=577895_ch8appef7.jpg" target="tileshopwindow" class="inline_block pmc_inline_block ts_canvas img_link" title="Click on image to zoom"><div class="ts_bar small" title="Click on image to zoom"></div><img src="/books/NBK577895/bin/ch8appef7.jpg" alt="Figure 8. Number of adverse events in 12 months." class="tileshop" title="Click on image to zoom" /></a></div><h3><span class="label">Figure 8</span><span class="title">Number of adverse events in 12 months</span></h3></div></div></div></div><div id="ch8.appf"><h3>Appendix F. GRADE tables</h3><div id="ch8.appf.s1"><h4>F.1. People with normocalcaemic PHPT and presence of bone end-organ effects</h4><div id="ch8.appf.tab1" class="table"><h3><span class="label">Table 10</span><span class="title">Clinical evidence profile: Alendronate + Vitamin D versus Vitamin D only</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK577895/table/ch8.appf.tab1/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__ch8.appf.tab1_lrgtbl__"><table class="no_bottom_margin"><thead><tr><th id="hd_h_ch8.appf.tab1_1_1_1_1" colspan="7" rowspan="1" style="text-align:center;vertical-align:middle;">Quality assessment</th><th id="hd_h_ch8.appf.tab1_1_1_1_2" colspan="2" rowspan="1" style="text-align:center;vertical-align:middle;">№ of patients</th><th id="hd_h_ch8.appf.tab1_1_1_1_3" colspan="2" rowspan="1" style="text-align:center;vertical-align:middle;">Effect</th><th id="hd_h_ch8.appf.tab1_1_1_1_4" rowspan="2" colspan="1" headers="hd_h_ch8.appf.tab1_1_1_1_4" style="text-align:center;vertical-align:middle;">Quality</th><th id="hd_h_ch8.appf.tab1_1_1_1_5" rowspan="2" colspan="1" headers="hd_h_ch8.appf.tab1_1_1_1_5" style="text-align:center;vertical-align:middle;">Importance</th></tr><tr><th headers="hd_h_ch8.appf.tab1_1_1_1_1" id="hd_h_ch8.appf.tab1_1_1_2_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">№ of studies</th><th headers="hd_h_ch8.appf.tab1_1_1_1_1" id="hd_h_ch8.appf.tab1_1_1_2_2" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">Study design</th><th headers="hd_h_ch8.appf.tab1_1_1_1_1" id="hd_h_ch8.appf.tab1_1_1_2_3" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">Risk of bias</th><th headers="hd_h_ch8.appf.tab1_1_1_1_1" id="hd_h_ch8.appf.tab1_1_1_2_4" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">Inconsistency</th><th headers="hd_h_ch8.appf.tab1_1_1_1_1" id="hd_h_ch8.appf.tab1_1_1_2_5" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">Indirectness</th><th headers="hd_h_ch8.appf.tab1_1_1_1_1" id="hd_h_ch8.appf.tab1_1_1_2_6" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">Imprecision</th><th headers="hd_h_ch8.appf.tab1_1_1_1_1" id="hd_h_ch8.appf.tab1_1_1_2_7" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">Other considerations</th><th headers="hd_h_ch8.appf.tab1_1_1_1_2" id="hd_h_ch8.appf.tab1_1_1_2_8" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">Alendronate + Vitamin D</th><th headers="hd_h_ch8.appf.tab1_1_1_1_2" id="hd_h_ch8.appf.tab1_1_1_2_9" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">Vitamin D only</th><th headers="hd_h_ch8.appf.tab1_1_1_1_3" id="hd_h_ch8.appf.tab1_1_1_2_10" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">Relative (95% CI)</th><th headers="hd_h_ch8.appf.tab1_1_1_1_3" id="hd_h_ch8.appf.tab1_1_1_2_11" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">Absolute (95% CI)</th></tr></thead><tbody><tr><th headers="hd_h_ch8.appf.tab1_1_1_1_1 hd_h_ch8.appf.tab1_1_1_2_1 hd_h_ch8.appf.tab1_1_1_2_2 hd_h_ch8.appf.tab1_1_1_2_3 hd_h_ch8.appf.tab1_1_1_2_4 hd_h_ch8.appf.tab1_1_1_2_5 hd_h_ch8.appf.tab1_1_1_2_6 hd_h_ch8.appf.tab1_1_1_2_7 hd_h_ch8.appf.tab1_1_1_1_2 hd_h_ch8.appf.tab1_1_1_2_8 hd_h_ch8.appf.tab1_1_1_2_9 hd_h_ch8.appf.tab1_1_1_1_3 hd_h_ch8.appf.tab1_1_1_2_10 hd_h_ch8.appf.tab1_1_1_2_11 hd_h_ch8.appf.tab1_1_1_1_4 hd_h_ch8.appf.tab1_1_1_1_5" id="hd_b_ch8.appf.tab1_1_1_1_1" colspan="13" rowspan="1" style="text-align:left;vertical-align:top;">Lumbar spine BMD (follow up: 12 months; assessed with: g/cm2)</th></tr><tr><td headers="hd_h_ch8.appf.tab1_1_1_1_1 hd_h_ch8.appf.tab1_1_1_2_1 hd_b_ch8.appf.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">1</td><td headers="hd_h_ch8.appf.tab1_1_1_1_1 hd_h_ch8.appf.tab1_1_1_2_2 hd_b_ch8.appf.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">randomised trials</td><td headers="hd_h_ch8.appf.tab1_1_1_1_1 hd_h_ch8.appf.tab1_1_1_2_3 hd_b_ch8.appf.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">serious<sup><a class="bk_pop" href="#ch8.appf.tab1_1">a</a></sup></td><td headers="hd_h_ch8.appf.tab1_1_1_1_1 hd_h_ch8.appf.tab1_1_1_2_4 hd_b_ch8.appf.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">not serious</td><td headers="hd_h_ch8.appf.tab1_1_1_1_1 hd_h_ch8.appf.tab1_1_1_2_5 hd_b_ch8.appf.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">not serious</td><td headers="hd_h_ch8.appf.tab1_1_1_1_1 hd_h_ch8.appf.tab1_1_1_2_6 hd_b_ch8.appf.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">serious<sup><a class="bk_pop" href="#ch8.appf.tab1_2">b</a></sup></td><td headers="hd_h_ch8.appf.tab1_1_1_1_1 hd_h_ch8.appf.tab1_1_1_2_7 hd_b_ch8.appf.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">none</td><td headers="hd_h_ch8.appf.tab1_1_1_1_2 hd_h_ch8.appf.tab1_1_1_2_8 hd_b_ch8.appf.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:top;">Mean (SD) 0.819 (0.0714)</td><td headers="hd_h_ch8.appf.tab1_1_1_1_2 hd_h_ch8.appf.tab1_1_1_2_9 hd_b_ch8.appf.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:top;">Mean (SD) 0.759 (0.072)</td><td headers="hd_h_ch8.appf.tab1_1_1_1_3 hd_h_ch8.appf.tab1_1_1_2_10 hd_b_ch8.appf.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:top;">-</td><td headers="hd_h_ch8.appf.tab1_1_1_1_3 hd_h_ch8.appf.tab1_1_1_2_11 hd_b_ch8.appf.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:top;">MD <b>0.06 higher</b> (0.01 higher to 0.11 higher)</td><td headers="hd_h_ch8.appf.tab1_1_1_1_4 hd_b_ch8.appf.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:top;">
|
||
<p>⨁⨁◯◯</p>
|
||
<p>LOW</p>
|
||
</td><td headers="hd_h_ch8.appf.tab1_1_1_1_5 hd_b_ch8.appf.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">IMPORTANT</td></tr><tr><th headers="hd_h_ch8.appf.tab1_1_1_1_1 hd_h_ch8.appf.tab1_1_1_2_1 hd_h_ch8.appf.tab1_1_1_2_2 hd_h_ch8.appf.tab1_1_1_2_3 hd_h_ch8.appf.tab1_1_1_2_4 hd_h_ch8.appf.tab1_1_1_2_5 hd_h_ch8.appf.tab1_1_1_2_6 hd_h_ch8.appf.tab1_1_1_2_7 hd_h_ch8.appf.tab1_1_1_1_2 hd_h_ch8.appf.tab1_1_1_2_8 hd_h_ch8.appf.tab1_1_1_2_9 hd_h_ch8.appf.tab1_1_1_1_3 hd_h_ch8.appf.tab1_1_1_2_10 hd_h_ch8.appf.tab1_1_1_2_11 hd_h_ch8.appf.tab1_1_1_1_4 hd_h_ch8.appf.tab1_1_1_1_5" id="hd_b_ch8.appf.tab1_1_1_3_1" colspan="13" rowspan="1" style="text-align:left;vertical-align:bottom;">Incidence of hypercalcaemia or hypercalciuria (follow up: 12 months)</th></tr><tr><td headers="hd_h_ch8.appf.tab1_1_1_1_1 hd_h_ch8.appf.tab1_1_1_2_1 hd_b_ch8.appf.tab1_1_1_3_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">1</td><td headers="hd_h_ch8.appf.tab1_1_1_1_1 hd_h_ch8.appf.tab1_1_1_2_2 hd_b_ch8.appf.tab1_1_1_3_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">randomised trials</td><td headers="hd_h_ch8.appf.tab1_1_1_1_1 hd_h_ch8.appf.tab1_1_1_2_3 hd_b_ch8.appf.tab1_1_1_3_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">serious<sup><a class="bk_pop" href="#ch8.appf.tab1_1">a</a></sup></td><td headers="hd_h_ch8.appf.tab1_1_1_1_1 hd_h_ch8.appf.tab1_1_1_2_4 hd_b_ch8.appf.tab1_1_1_3_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">not serious</td><td headers="hd_h_ch8.appf.tab1_1_1_1_1 hd_h_ch8.appf.tab1_1_1_2_5 hd_b_ch8.appf.tab1_1_1_3_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">serious<sup><a class="bk_pop" href="#ch8.appf.tab1_3">c</a></sup></td><td headers="hd_h_ch8.appf.tab1_1_1_1_1 hd_h_ch8.appf.tab1_1_1_2_6 hd_b_ch8.appf.tab1_1_1_3_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">not serious</td><td headers="hd_h_ch8.appf.tab1_1_1_1_1 hd_h_ch8.appf.tab1_1_1_2_7 hd_b_ch8.appf.tab1_1_1_3_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">none</td><td headers="hd_h_ch8.appf.tab1_1_1_1_2 hd_h_ch8.appf.tab1_1_1_2_8 hd_b_ch8.appf.tab1_1_1_3_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:top;">0/15 (0.0%)</td><td headers="hd_h_ch8.appf.tab1_1_1_1_2 hd_h_ch8.appf.tab1_1_1_2_9 hd_b_ch8.appf.tab1_1_1_3_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:top;">0/15 (0.0%)</td><td headers="hd_h_ch8.appf.tab1_1_1_1_3 hd_h_ch8.appf.tab1_1_1_2_10 hd_b_ch8.appf.tab1_1_1_3_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:top;">not estimable</td><td headers="hd_h_ch8.appf.tab1_1_1_1_3 hd_h_ch8.appf.tab1_1_1_2_11 hd_b_ch8.appf.tab1_1_1_3_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:top;"><b>0 fewer per 1000</b> (from 120 more to 120 fewer)</td><td headers="hd_h_ch8.appf.tab1_1_1_1_4 hd_b_ch8.appf.tab1_1_1_3_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:top;">
|
||
<p>⨁⨁◯◯</p>
|
||
<p>LOW</p>
|
||
</td><td headers="hd_h_ch8.appf.tab1_1_1_1_5 hd_b_ch8.appf.tab1_1_1_3_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">IMPORTANT</td></tr></tbody></table></div><div><div><dl class="temp-labeled-list small"><dt>a</dt><dd><div id="ch8.appf.tab1_1"><p class="no_margin">Downgraded by one increment if the majority of the evidence was at high risk of bias and downgraded by two increments if the majority of the evidence was at very high risk of bias</p></div></dd><dt>b</dt><dd><div id="ch8.appf.tab1_2"><p class="no_margin">Downgraded by one increment if the confidence interval crossed one MID, and downgraded by two increments if the confidence interval crossed both MIDs</p></div></dd><dt>c</dt><dd><div id="ch8.appf.tab1_3"><p class="no_margin">Outcome of interest listed in the protocol is the number of persistent hypercalcaemia cases</p></div></dd></dl></div></div></div></div><div id="ch8.appf.s2"><h4>F.2. People with hypercalcaemic PHPT and presence of bone end-organ effects</h4><div id="ch8.appf.tab2" class="table"><h3><span class="label">Table 11</span><span class="title">Clinical evidence profile: Alendronate versus Placebo</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK577895/table/ch8.appf.tab2/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__ch8.appf.tab2_lrgtbl__"><table class="no_bottom_margin"><thead><tr><th id="hd_h_ch8.appf.tab2_1_1_1_1" colspan="7" rowspan="1" style="text-align:center;vertical-align:middle;">Quality assessment</th><th id="hd_h_ch8.appf.tab2_1_1_1_2" colspan="2" rowspan="1" style="text-align:center;vertical-align:middle;">№ of patients</th><th id="hd_h_ch8.appf.tab2_1_1_1_3" colspan="2" rowspan="1" style="text-align:center;vertical-align:middle;">Effect</th><th id="hd_h_ch8.appf.tab2_1_1_1_4" rowspan="2" colspan="1" headers="hd_h_ch8.appf.tab2_1_1_1_4" style="text-align:center;vertical-align:middle;">Quality</th><th id="hd_h_ch8.appf.tab2_1_1_1_5" rowspan="2" colspan="1" headers="hd_h_ch8.appf.tab2_1_1_1_5" style="text-align:center;vertical-align:middle;">Importance</th></tr><tr><th headers="hd_h_ch8.appf.tab2_1_1_1_1" id="hd_h_ch8.appf.tab2_1_1_2_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">№ of studies</th><th headers="hd_h_ch8.appf.tab2_1_1_1_1" id="hd_h_ch8.appf.tab2_1_1_2_2" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">Study design</th><th headers="hd_h_ch8.appf.tab2_1_1_1_1" id="hd_h_ch8.appf.tab2_1_1_2_3" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">Risk of bias</th><th headers="hd_h_ch8.appf.tab2_1_1_1_1" id="hd_h_ch8.appf.tab2_1_1_2_4" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">Inconsistency</th><th headers="hd_h_ch8.appf.tab2_1_1_1_1" id="hd_h_ch8.appf.tab2_1_1_2_5" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">Indirectness</th><th headers="hd_h_ch8.appf.tab2_1_1_1_1" id="hd_h_ch8.appf.tab2_1_1_2_6" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">Imprecision</th><th headers="hd_h_ch8.appf.tab2_1_1_1_1" id="hd_h_ch8.appf.tab2_1_1_2_7" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">Other considerations</th><th headers="hd_h_ch8.appf.tab2_1_1_1_2" id="hd_h_ch8.appf.tab2_1_1_2_8" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">Alendronate</th><th headers="hd_h_ch8.appf.tab2_1_1_1_2" id="hd_h_ch8.appf.tab2_1_1_2_9" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">Placebo</th><th headers="hd_h_ch8.appf.tab2_1_1_1_3" id="hd_h_ch8.appf.tab2_1_1_2_10" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">Relative (95% CI)</th><th headers="hd_h_ch8.appf.tab2_1_1_1_3" id="hd_h_ch8.appf.tab2_1_1_2_11" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">Absolute (95% CI)</th></tr></thead><tbody><tr><th headers="hd_h_ch8.appf.tab2_1_1_1_1 hd_h_ch8.appf.tab2_1_1_2_1 hd_h_ch8.appf.tab2_1_1_2_2 hd_h_ch8.appf.tab2_1_1_2_3 hd_h_ch8.appf.tab2_1_1_2_4 hd_h_ch8.appf.tab2_1_1_2_5 hd_h_ch8.appf.tab2_1_1_2_6 hd_h_ch8.appf.tab2_1_1_2_7 hd_h_ch8.appf.tab2_1_1_1_2 hd_h_ch8.appf.tab2_1_1_2_8 hd_h_ch8.appf.tab2_1_1_2_9 hd_h_ch8.appf.tab2_1_1_1_3 hd_h_ch8.appf.tab2_1_1_2_10 hd_h_ch8.appf.tab2_1_1_2_11 hd_h_ch8.appf.tab2_1_1_1_4 hd_h_ch8.appf.tab2_1_1_1_5" id="hd_b_ch8.appf.tab2_1_1_1_1" colspan="13" rowspan="1" style="text-align:left;vertical-align:top;">Lumbar spine BMD (follow up: 48 weeks; assessed with: % change from baseline)</th></tr><tr><td headers="hd_h_ch8.appf.tab2_1_1_1_1 hd_h_ch8.appf.tab2_1_1_2_1 hd_b_ch8.appf.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">1</td><td headers="hd_h_ch8.appf.tab2_1_1_1_1 hd_h_ch8.appf.tab2_1_1_2_2 hd_b_ch8.appf.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">randomised trials</td><td headers="hd_h_ch8.appf.tab2_1_1_1_1 hd_h_ch8.appf.tab2_1_1_2_3 hd_b_ch8.appf.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">very serious<sup><a class="bk_pop" href="#ch8.appf.tab2_1">a</a></sup></td><td headers="hd_h_ch8.appf.tab2_1_1_1_1 hd_h_ch8.appf.tab2_1_1_2_4 hd_b_ch8.appf.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">not serious</td><td headers="hd_h_ch8.appf.tab2_1_1_1_1 hd_h_ch8.appf.tab2_1_1_2_5 hd_b_ch8.appf.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">not serious</td><td headers="hd_h_ch8.appf.tab2_1_1_1_1 hd_h_ch8.appf.tab2_1_1_2_6 hd_b_ch8.appf.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">not serious</td><td headers="hd_h_ch8.appf.tab2_1_1_1_1 hd_h_ch8.appf.tab2_1_1_2_7 hd_b_ch8.appf.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">none</td><td headers="hd_h_ch8.appf.tab2_1_1_1_2 hd_h_ch8.appf.tab2_1_1_2_8 hd_b_ch8.appf.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:top;">Mean (SD) 3.79 (4.04)</td><td headers="hd_h_ch8.appf.tab2_1_1_1_2 hd_h_ch8.appf.tab2_1_1_2_9 hd_b_ch8.appf.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:top;">Mean (SD) 0.19 (2.8)</td><td headers="hd_h_ch8.appf.tab2_1_1_1_3 hd_h_ch8.appf.tab2_1_1_2_10 hd_b_ch8.appf.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:top;">-</td><td headers="hd_h_ch8.appf.tab2_1_1_1_3 hd_h_ch8.appf.tab2_1_1_2_11 hd_b_ch8.appf.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:top;">MD <b>3.6 higher</b> (1.45 higher to 5.75 higher)</td><td headers="hd_h_ch8.appf.tab2_1_1_1_4 hd_b_ch8.appf.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:top;">
|
||
<p>⨁⨁◯◯</p>
|
||
<p>LOW</p>
|
||
</td><td headers="hd_h_ch8.appf.tab2_1_1_1_5 hd_b_ch8.appf.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">IMPORTANT</td></tr><tr><th headers="hd_h_ch8.appf.tab2_1_1_1_1 hd_h_ch8.appf.tab2_1_1_2_1 hd_h_ch8.appf.tab2_1_1_2_2 hd_h_ch8.appf.tab2_1_1_2_3 hd_h_ch8.appf.tab2_1_1_2_4 hd_h_ch8.appf.tab2_1_1_2_5 hd_h_ch8.appf.tab2_1_1_2_6 hd_h_ch8.appf.tab2_1_1_2_7 hd_h_ch8.appf.tab2_1_1_1_2 hd_h_ch8.appf.tab2_1_1_2_8 hd_h_ch8.appf.tab2_1_1_2_9 hd_h_ch8.appf.tab2_1_1_1_3 hd_h_ch8.appf.tab2_1_1_2_10 hd_h_ch8.appf.tab2_1_1_2_11 hd_h_ch8.appf.tab2_1_1_1_4 hd_h_ch8.appf.tab2_1_1_1_5" id="hd_b_ch8.appf.tab2_1_1_3_1" colspan="13" rowspan="1" style="text-align:left;vertical-align:bottom;">Distal radius BMD (follow up: 48 weeks; assessed with: % change from baseline)</th></tr><tr><td headers="hd_h_ch8.appf.tab2_1_1_1_1 hd_h_ch8.appf.tab2_1_1_2_1 hd_b_ch8.appf.tab2_1_1_3_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">1</td><td headers="hd_h_ch8.appf.tab2_1_1_1_1 hd_h_ch8.appf.tab2_1_1_2_2 hd_b_ch8.appf.tab2_1_1_3_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">randomised trials</td><td headers="hd_h_ch8.appf.tab2_1_1_1_1 hd_h_ch8.appf.tab2_1_1_2_3 hd_b_ch8.appf.tab2_1_1_3_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">very serious<sup><a class="bk_pop" href="#ch8.appf.tab2_1">a</a></sup></td><td headers="hd_h_ch8.appf.tab2_1_1_1_1 hd_h_ch8.appf.tab2_1_1_2_4 hd_b_ch8.appf.tab2_1_1_3_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">not serious</td><td headers="hd_h_ch8.appf.tab2_1_1_1_1 hd_h_ch8.appf.tab2_1_1_2_5 hd_b_ch8.appf.tab2_1_1_3_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">not serious</td><td headers="hd_h_ch8.appf.tab2_1_1_1_1 hd_h_ch8.appf.tab2_1_1_2_6 hd_b_ch8.appf.tab2_1_1_3_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">serious<sup><a class="bk_pop" href="#ch8.appf.tab2_2">b</a></sup></td><td headers="hd_h_ch8.appf.tab2_1_1_1_1 hd_h_ch8.appf.tab2_1_1_2_7 hd_b_ch8.appf.tab2_1_1_3_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">none</td><td headers="hd_h_ch8.appf.tab2_1_1_1_2 hd_h_ch8.appf.tab2_1_1_2_8 hd_b_ch8.appf.tab2_1_1_3_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:top;">Mean (SD) 1.01 (2.32)</td><td headers="hd_h_ch8.appf.tab2_1_1_1_2 hd_h_ch8.appf.tab2_1_1_2_9 hd_b_ch8.appf.tab2_1_1_3_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:top;">Mean (SD) 0.07 (5.5)</td><td headers="hd_h_ch8.appf.tab2_1_1_1_3 hd_h_ch8.appf.tab2_1_1_2_10 hd_b_ch8.appf.tab2_1_1_3_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:top;">-</td><td headers="hd_h_ch8.appf.tab2_1_1_1_3 hd_h_ch8.appf.tab2_1_1_2_11 hd_b_ch8.appf.tab2_1_1_3_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:top;">MD <b>0.94 higher</b> (1.68 lower to 3.56 higher)</td><td headers="hd_h_ch8.appf.tab2_1_1_1_4 hd_b_ch8.appf.tab2_1_1_3_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:top;">
|
||
<p>⨁◯◯◯</p>
|
||
<p>VERY LOW</p>
|
||
</td><td headers="hd_h_ch8.appf.tab2_1_1_1_5 hd_b_ch8.appf.tab2_1_1_3_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">IMPORTANT</td></tr><tr><th headers="hd_h_ch8.appf.tab2_1_1_1_1 hd_h_ch8.appf.tab2_1_1_2_1 hd_h_ch8.appf.tab2_1_1_2_2 hd_h_ch8.appf.tab2_1_1_2_3 hd_h_ch8.appf.tab2_1_1_2_4 hd_h_ch8.appf.tab2_1_1_2_5 hd_h_ch8.appf.tab2_1_1_2_6 hd_h_ch8.appf.tab2_1_1_2_7 hd_h_ch8.appf.tab2_1_1_1_2 hd_h_ch8.appf.tab2_1_1_2_8 hd_h_ch8.appf.tab2_1_1_2_9 hd_h_ch8.appf.tab2_1_1_1_3 hd_h_ch8.appf.tab2_1_1_2_10 hd_h_ch8.appf.tab2_1_1_2_11 hd_h_ch8.appf.tab2_1_1_1_4 hd_h_ch8.appf.tab2_1_1_1_5" id="hd_b_ch8.appf.tab2_1_1_5_1" colspan="13" rowspan="1" style="text-align:left;vertical-align:bottom;">Number of serious adverse events (follow up: 48 weeks)</th></tr><tr><td headers="hd_h_ch8.appf.tab2_1_1_1_1 hd_h_ch8.appf.tab2_1_1_2_1 hd_b_ch8.appf.tab2_1_1_5_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">1</td><td headers="hd_h_ch8.appf.tab2_1_1_1_1 hd_h_ch8.appf.tab2_1_1_2_2 hd_b_ch8.appf.tab2_1_1_5_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">randomised trials</td><td headers="hd_h_ch8.appf.tab2_1_1_1_1 hd_h_ch8.appf.tab2_1_1_2_3 hd_b_ch8.appf.tab2_1_1_5_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">very serious<sup><a class="bk_pop" href="#ch8.appf.tab2_1">a</a></sup></td><td headers="hd_h_ch8.appf.tab2_1_1_1_1 hd_h_ch8.appf.tab2_1_1_2_4 hd_b_ch8.appf.tab2_1_1_5_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">not serious</td><td headers="hd_h_ch8.appf.tab2_1_1_1_1 hd_h_ch8.appf.tab2_1_1_2_5 hd_b_ch8.appf.tab2_1_1_5_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">not serious</td><td headers="hd_h_ch8.appf.tab2_1_1_1_1 hd_h_ch8.appf.tab2_1_1_2_6 hd_b_ch8.appf.tab2_1_1_5_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">very serious<sup><a class="bk_pop" href="#ch8.appf.tab2_2">b</a></sup></td><td headers="hd_h_ch8.appf.tab2_1_1_1_1 hd_h_ch8.appf.tab2_1_1_2_7 hd_b_ch8.appf.tab2_1_1_5_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">none</td><td headers="hd_h_ch8.appf.tab2_1_1_1_2 hd_h_ch8.appf.tab2_1_1_2_8 hd_b_ch8.appf.tab2_1_1_5_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:top;">2/20 (10.0%)</td><td headers="hd_h_ch8.appf.tab2_1_1_1_2 hd_h_ch8.appf.tab2_1_1_2_9 hd_b_ch8.appf.tab2_1_1_5_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:top;">3/20 (15.0%)</td><td headers="hd_h_ch8.appf.tab2_1_1_1_3 hd_h_ch8.appf.tab2_1_1_2_10 hd_b_ch8.appf.tab2_1_1_5_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:top;"><b>RR 0.67</b> (0.12 to 3.57)</td><td headers="hd_h_ch8.appf.tab2_1_1_1_3 hd_h_ch8.appf.tab2_1_1_2_11 hd_b_ch8.appf.tab2_1_1_5_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:top;"><b>49 fewer per 1000</b> (from 132 fewer to 385 more)</td><td headers="hd_h_ch8.appf.tab2_1_1_1_4 hd_b_ch8.appf.tab2_1_1_5_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:top;">
|
||
<p>⨁◯◯◯</p>
|
||
<p>VERY LOW</p>
|
||
</td><td headers="hd_h_ch8.appf.tab2_1_1_1_5 hd_b_ch8.appf.tab2_1_1_5_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">IMPORTANT</td></tr><tr><th headers="hd_h_ch8.appf.tab2_1_1_1_1 hd_h_ch8.appf.tab2_1_1_2_1 hd_h_ch8.appf.tab2_1_1_2_2 hd_h_ch8.appf.tab2_1_1_2_3 hd_h_ch8.appf.tab2_1_1_2_4 hd_h_ch8.appf.tab2_1_1_2_5 hd_h_ch8.appf.tab2_1_1_2_6 hd_h_ch8.appf.tab2_1_1_2_7 hd_h_ch8.appf.tab2_1_1_1_2 hd_h_ch8.appf.tab2_1_1_2_8 hd_h_ch8.appf.tab2_1_1_2_9 hd_h_ch8.appf.tab2_1_1_1_3 hd_h_ch8.appf.tab2_1_1_2_10 hd_h_ch8.appf.tab2_1_1_2_11 hd_h_ch8.appf.tab2_1_1_1_4 hd_h_ch8.appf.tab2_1_1_1_5" id="hd_b_ch8.appf.tab2_1_1_7_1" colspan="13" rowspan="1" style="text-align:left;vertical-align:top;">Number of fractures (follow up: 12 months)</th></tr><tr><td headers="hd_h_ch8.appf.tab2_1_1_1_1 hd_h_ch8.appf.tab2_1_1_2_1 hd_b_ch8.appf.tab2_1_1_7_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">1</td><td headers="hd_h_ch8.appf.tab2_1_1_1_1 hd_h_ch8.appf.tab2_1_1_2_2 hd_b_ch8.appf.tab2_1_1_7_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">randomised trials</td><td headers="hd_h_ch8.appf.tab2_1_1_1_1 hd_h_ch8.appf.tab2_1_1_2_3 hd_b_ch8.appf.tab2_1_1_7_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">very serious<sup><a class="bk_pop" href="#ch8.appf.tab2_1">a</a></sup></td><td headers="hd_h_ch8.appf.tab2_1_1_1_1 hd_h_ch8.appf.tab2_1_1_2_4 hd_b_ch8.appf.tab2_1_1_7_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">not serious</td><td headers="hd_h_ch8.appf.tab2_1_1_1_1 hd_h_ch8.appf.tab2_1_1_2_5 hd_b_ch8.appf.tab2_1_1_7_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">not serious</td><td headers="hd_h_ch8.appf.tab2_1_1_1_1 hd_h_ch8.appf.tab2_1_1_2_6 hd_b_ch8.appf.tab2_1_1_7_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">not serious</td><td headers="hd_h_ch8.appf.tab2_1_1_1_1 hd_h_ch8.appf.tab2_1_1_2_7 hd_b_ch8.appf.tab2_1_1_7_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">none</td><td headers="hd_h_ch8.appf.tab2_1_1_1_2 hd_h_ch8.appf.tab2_1_1_2_8 hd_b_ch8.appf.tab2_1_1_7_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:top;">0/18 (0.0%)</td><td headers="hd_h_ch8.appf.tab2_1_1_1_2 hd_h_ch8.appf.tab2_1_1_2_9 hd_b_ch8.appf.tab2_1_1_7_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:top;">0/19 (0.0%)</td><td headers="hd_h_ch8.appf.tab2_1_1_1_3 hd_h_ch8.appf.tab2_1_1_2_10 hd_b_ch8.appf.tab2_1_1_7_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:top;">not estimable</td><td headers="hd_h_ch8.appf.tab2_1_1_1_3 hd_h_ch8.appf.tab2_1_1_2_11 hd_b_ch8.appf.tab2_1_1_7_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:top;"><b>0 fewer per 1000</b> (from 100 more to 100 fewer)</td><td headers="hd_h_ch8.appf.tab2_1_1_1_4 hd_b_ch8.appf.tab2_1_1_7_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:top;">
|
||
<p>⨁⨁◯◯</p>
|
||
<p>LOW</p>
|
||
</td><td headers="hd_h_ch8.appf.tab2_1_1_1_5 hd_b_ch8.appf.tab2_1_1_7_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">IMPORTANT</td></tr><tr><th headers="hd_h_ch8.appf.tab2_1_1_1_1 hd_h_ch8.appf.tab2_1_1_2_1 hd_h_ch8.appf.tab2_1_1_2_2 hd_h_ch8.appf.tab2_1_1_2_3 hd_h_ch8.appf.tab2_1_1_2_4 hd_h_ch8.appf.tab2_1_1_2_5 hd_h_ch8.appf.tab2_1_1_2_6 hd_h_ch8.appf.tab2_1_1_2_7 hd_h_ch8.appf.tab2_1_1_1_2 hd_h_ch8.appf.tab2_1_1_2_8 hd_h_ch8.appf.tab2_1_1_2_9 hd_h_ch8.appf.tab2_1_1_1_3 hd_h_ch8.appf.tab2_1_1_2_10 hd_h_ch8.appf.tab2_1_1_2_11 hd_h_ch8.appf.tab2_1_1_1_4 hd_h_ch8.appf.tab2_1_1_1_5" id="hd_b_ch8.appf.tab2_1_1_9_1" colspan="13" rowspan="1" style="text-align:left;vertical-align:top;">Number of adverse events (follow up: 12 months)</th></tr><tr><td headers="hd_h_ch8.appf.tab2_1_1_1_1 hd_h_ch8.appf.tab2_1_1_2_1 hd_b_ch8.appf.tab2_1_1_9_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">1</td><td headers="hd_h_ch8.appf.tab2_1_1_1_1 hd_h_ch8.appf.tab2_1_1_2_2 hd_b_ch8.appf.tab2_1_1_9_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">randomised trials</td><td headers="hd_h_ch8.appf.tab2_1_1_1_1 hd_h_ch8.appf.tab2_1_1_2_3 hd_b_ch8.appf.tab2_1_1_9_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">very serious<sup><a class="bk_pop" href="#ch8.appf.tab2_1">a</a></sup></td><td headers="hd_h_ch8.appf.tab2_1_1_1_1 hd_h_ch8.appf.tab2_1_1_2_4 hd_b_ch8.appf.tab2_1_1_9_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">not serious</td><td headers="hd_h_ch8.appf.tab2_1_1_1_1 hd_h_ch8.appf.tab2_1_1_2_5 hd_b_ch8.appf.tab2_1_1_9_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">not serious</td><td headers="hd_h_ch8.appf.tab2_1_1_1_1 hd_h_ch8.appf.tab2_1_1_2_6 hd_b_ch8.appf.tab2_1_1_9_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">not serious</td><td headers="hd_h_ch8.appf.tab2_1_1_1_1 hd_h_ch8.appf.tab2_1_1_2_7 hd_b_ch8.appf.tab2_1_1_9_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">none</td><td headers="hd_h_ch8.appf.tab2_1_1_1_2 hd_h_ch8.appf.tab2_1_1_2_8 hd_b_ch8.appf.tab2_1_1_9_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:top;">0/18 (0.0%)</td><td headers="hd_h_ch8.appf.tab2_1_1_1_2 hd_h_ch8.appf.tab2_1_1_2_9 hd_b_ch8.appf.tab2_1_1_9_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:top;">0/19 (0.0%)</td><td headers="hd_h_ch8.appf.tab2_1_1_1_3 hd_h_ch8.appf.tab2_1_1_2_10 hd_b_ch8.appf.tab2_1_1_9_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:top;">not estimable</td><td headers="hd_h_ch8.appf.tab2_1_1_1_3 hd_h_ch8.appf.tab2_1_1_2_11 hd_b_ch8.appf.tab2_1_1_9_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:top;"><b>0 fewer per 1000</b> (from 100 more to 100 fewer)</td><td headers="hd_h_ch8.appf.tab2_1_1_1_4 hd_b_ch8.appf.tab2_1_1_9_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:top;">
|
||
<p>⨁⨁◯◯</p>
|
||
<p>LOW</p>
|
||
</td><td headers="hd_h_ch8.appf.tab2_1_1_1_5 hd_b_ch8.appf.tab2_1_1_9_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">IMPORTANT</td></tr></tbody></table></div><div><div><dl class="temp-labeled-list small"><dt>a</dt><dd><div id="ch8.appf.tab2_1"><p class="no_margin">Downgraded by one increment if the majority of the evidence was at high risk of bias and downgraded by two increments if the majority of the evidence was at very high risk of bias</p></div></dd><dt>b</dt><dd><div id="ch8.appf.tab2_2"><p class="no_margin">Downgraded by one increment if the confidence interval crossed one MID, and downgraded by two increments if the confidence interval crossed both MIDs</p></div></dd></dl></div></div></div></div></div><div id="ch8.appg"><h3>Appendix G. Health economic evidence selection</h3><div id="ch8.appg.fig1" class="figure bk_fig"><div class="graphic"><a href="/core/lw/2.0/html/tileshop_pmc/tileshop_pmc_inline.html?title=Figure%209.%20Flow%20chart%20of%20health%20economic%20study%20selection%20for%20the%20guideline.&p=BOOKS&id=577895_ch8appgf1.jpg" target="tileshopwindow" class="inline_block pmc_inline_block ts_canvas img_link" title="Click on image to zoom"><div class="ts_bar small" title="Click on image to zoom"></div><img src="/books/NBK577895/bin/ch8appgf1.jpg" alt="Figure 9. Flow chart of health economic study selection for the guideline." class="tileshop" title="Click on image to zoom" /></a></div><h3><span class="label">Figure 9</span><span class="title">Flow chart of health economic study selection for the guideline</span></h3><div class="caption"><p>* Non-relevant population, intervention, comparison, design or setting; non-English language</p></div></div></div><div id="ch8.apph"><h3>Appendix H. Health economic evidence tables</h3><p>No relevant health economic studies were identified for this question.</p></div><div id="ch8.appi"><h3>Appendix I. Excluded studies</h3><div id="ch8.appi.s1"><h4>I.1. Excluded clinical studies</h4><div id="ch8.appi.tab1" class="table"><h3><span class="label">Table 12</span><span class="title">Studies excluded from the clinical review</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK577895/table/ch8.appi.tab1/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__ch8.appi.tab1_lrgtbl__"><table><thead><tr><th id="hd_h_ch8.appi.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Study</th><th id="hd_h_ch8.appi.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Exclusion reason</th></tr></thead><tbody><tr><td headers="hd_h_ch8.appi.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Akbaba 2013<a class="bk_pop" href="#ch8.ref1"><sup>1</sup></a></td><td headers="hd_h_ch8.appi.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Incorrect comparator (raloxifene)</td></tr><tr><td headers="hd_h_ch8.appi.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Brardi 2015<a class="bk_pop" href="#ch8.ref2"><sup>2</sup></a></td><td headers="hd_h_ch8.appi.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Incorrect interventions</td></tr><tr><td headers="hd_h_ch8.appi.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Casez 2003<a class="bk_pop" href="#ch8.ref3"><sup>3</sup></a></td><td headers="hd_h_ch8.appi.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Incorrect interventions</td></tr><tr><td headers="hd_h_ch8.appi.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Eller-Vainicher 2018<a class="bk_pop" href="#ch8.ref7"><sup>7</sup></a></td><td headers="hd_h_ch8.appi.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Not a randomised controlled trial</td></tr><tr><td headers="hd_h_ch8.appi.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Hamdy 1987<a class="bk_pop" href="#ch8.ref8"><sup>8</sup></a></td><td headers="hd_h_ch8.appi.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Non-comparative study</td></tr><tr><td headers="hd_h_ch8.appi.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Hassani 2001<a class="bk_pop" href="#ch8.ref9"><sup>9</sup></a></td><td headers="hd_h_ch8.appi.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Not a randomised controlled trial</td></tr><tr><td headers="hd_h_ch8.appi.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Horiuchi 2002<a class="bk_pop" href="#ch8.ref10"><sup>10</sup></a></td><td headers="hd_h_ch8.appi.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Inappropriate intervention – 2 week administration only of oral etidronate. This bisphosphonate is no longer used.</td></tr><tr><td headers="hd_h_ch8.appi.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Khan 2009<a class="bk_pop" href="#ch8.ref14"><sup>14</sup></a></td><td headers="hd_h_ch8.appi.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Post-hoc subgroup analysis of a previously published study</td></tr><tr><td headers="hd_h_ch8.appi.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Khan 2014<a class="bk_pop" href="#ch8.ref13"><sup>13</sup></a></td><td headers="hd_h_ch8.appi.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Conference abstract</td></tr><tr><td headers="hd_h_ch8.appi.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Khan 2015<a class="bk_pop" href="#ch8.ref12"><sup>12</sup></a></td><td headers="hd_h_ch8.appi.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Incorrect interventions (calcimimetics)</td></tr><tr><td headers="hd_h_ch8.appi.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Martin 2010<a class="bk_pop" href="#ch8.ref16"><sup>16</sup></a></td><td headers="hd_h_ch8.appi.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Conference abstract</td></tr><tr><td headers="hd_h_ch8.appi.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Narayan 2007<a class="bk_pop" href="#ch8.ref17"><sup>17</sup></a></td><td headers="hd_h_ch8.appi.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Incorrect population (end stage renal disease)</td></tr><tr><td headers="hd_h_ch8.appi.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Parker 2002<a class="bk_pop" href="#ch8.ref20"><sup>20</sup></a></td><td headers="hd_h_ch8.appi.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Not a randomised controlled trial</td></tr><tr><td headers="hd_h_ch8.appi.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Peacock 2005<a class="bk_pop" href="#ch8.ref22"><sup>22</sup></a></td><td headers="hd_h_ch8.appi.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Incorrect interventions (calcimimetics)</td></tr><tr><td headers="hd_h_ch8.appi.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Peacock 2009<a class="bk_pop" href="#ch8.ref23"><sup>23</sup></a></td><td headers="hd_h_ch8.appi.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Open label non-comparative extension study of an RCT</td></tr><tr><td headers="hd_h_ch8.appi.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Peacock 2011<a class="bk_pop" href="#ch8.ref21"><sup>21</sup></a></td><td headers="hd_h_ch8.appi.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Pooled analysis of 3 clinical trials (checked for references)</td></tr><tr><td headers="hd_h_ch8.appi.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Reasner 1993<a class="bk_pop" href="#ch8.ref24"><sup>24</sup></a></td><td headers="hd_h_ch8.appi.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Dose study</td></tr><tr><td headers="hd_h_ch8.appi.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Rossini 2001<a class="bk_pop" href="#ch8.ref25"><sup>25</sup></a></td><td headers="hd_h_ch8.appi.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Comparative outcomes not available</td></tr><tr><td headers="hd_h_ch8.appi.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Sankaran 2010<a class="bk_pop" href="#ch8.ref26"><sup>26</sup></a></td><td headers="hd_h_ch8.appi.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Non-systematic literature review</td></tr><tr><td headers="hd_h_ch8.appi.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Schwarz 2014<a class="bk_pop" href="#ch8.ref27"><sup>27</sup></a></td><td headers="hd_h_ch8.appi.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Incorrect interventions (calcimimetics)</td></tr><tr><td headers="hd_h_ch8.appi.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Shoback 2003<a class="bk_pop" href="#ch8.ref28"><sup>28</sup></a></td><td headers="hd_h_ch8.appi.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Incorrect interventions (calcimimetics)</td></tr><tr><td headers="hd_h_ch8.appi.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Szczech 2004<a class="bk_pop" href="#ch8.ref29"><sup>29</sup></a></td><td headers="hd_h_ch8.appi.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Non-systematic literature review</td></tr></tbody></table></div></div></div><div id="ch8.appi.s2"><h4>I.2. Excluded health economic studies</h4><p>None.</p></div></div></div><div class="bk_prnt_sctn"><h2>Tables</h2><div class="whole_rhythm bk_prnt_obj bk_first_prnt_obj"><div id="ch8.tab1" class="table"><h3><span class="label">Table 1</span><span class="title">PICO characteristics of review question</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK577895/table/ch8.tab1/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__ch8.tab1_lrgtbl__"><table><tbody><tr><th id="hd_b_ch8.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Population</th><td headers="hd_b_ch8.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
||
<p>Adults (18 years or over) with confirmed primary hyperparathyroidism</p>
|
||
<p>Strata (the following groups are to be reported separately):
|
||
<ul id="ch8.l1"><li id="ch8.lt1" class="half_rhythm"><div>Absence/presence of bone end-organ effects (bone end-organ effects defined as history of fragility fractures or osteoporosis (BMD T-score <-2.5 at any site)</div></li><li id="ch8.lt2" class="half_rhythm"><div>People with normocalcaemic PHPT</div></li><li id="ch8.lt3" class="half_rhythm"><div>Previous parathyroidectomy</div></li><li id="ch8.lt4" class="half_rhythm"><div>Pregnant women</div></li></ul></p>
|
||
</td></tr><tr><th id="hd_b_ch8.tab1_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Interventions</th><td headers="hd_b_ch8.tab1_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Oral or IV bisphosphonates</td></tr><tr><th id="hd_b_ch8.tab1_1_1_3_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Comparisons</th><td headers="hd_b_ch8.tab1_1_1_3_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Placebo; no treatment; calcimimetics; surgery; combination treatment</td></tr><tr><th id="hd_b_ch8.tab1_1_1_4_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Outcomes</th><td headers="hd_b_ch8.tab1_1_1_4_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Health-related quality of life; mortality; deterioration in renal function; fractures; occurrence of kidney stones; persistent hypercalcaemia; BMD (lumbar spine or distal radius); cardiovascular events; adverse events; cancer incidence</td></tr><tr><th id="hd_b_ch8.tab1_1_1_5_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Study design</th><td headers="hd_b_ch8.tab1_1_1_5_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">RCTs and systematic reviews of RCTs</td></tr></tbody></table></div></div></div><div class="whole_rhythm bk_prnt_obj"><div id="ch8.tab2" class="table"><h3><span class="label">Table 2</span><span class="title">Summary of studies included in the evidence review</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK577895/table/ch8.tab2/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__ch8.tab2_lrgtbl__"><table><thead><tr><th id="hd_h_ch8.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Study</th><th id="hd_h_ch8.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Intervention and comparison</th><th id="hd_h_ch8.tab2_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Population</th><th id="hd_h_ch8.tab2_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Follow-up</th><th id="hd_h_ch8.tab2_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Outcomes</th></tr></thead><tbody><tr><td headers="hd_h_ch8.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Cesareo 2015<a class="bk_pop" href="#ch8.ref4"><sup>4</sup></a></td><td headers="hd_h_ch8.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Alendronate + Vitamin D versus Vitamin D only</td><td headers="hd_h_ch8.tab2_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
||
<p>Normocalcaemic osteoporotic postmenopausal women with PHPT (inclusion criteria was BMD T score <−2.5 at ≥1 skeletal site)</p>
|
||
<p>Stratum analysed in: normocalcaemic PHPT and presence of bone end-organ effects</p>
|
||
</td><td headers="hd_h_ch8.tab2_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">12 months</td><td headers="hd_h_ch8.tab2_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
||
<p>Lumbar spine BMD</p>
|
||
<p>Incidence of hypercalcaemia or hypercalciuria</p>
|
||
</td></tr><tr><td headers="hd_h_ch8.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Chow 2003<a class="bk_pop" href="#ch8.ref5"><sup>5</sup></a></td><td headers="hd_h_ch8.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Alendronate versus Placebo</td><td headers="hd_h_ch8.tab2_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
||
<p>Included participants were “generally osteoporotic” postmenopausal women with PHPT (no other details given except baseline BMD T score of −2.54 ± 1.25 at lumbar spine and −3.58 ± 1.43 at distal third of radius)</p>
|
||
<p>Stratum analysed in: hypercalcaemic PHPT and presence of bone end-organ effects</p>
|
||
</td><td headers="hd_h_ch8.tab2_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">48 weeks</td><td headers="hd_h_ch8.tab2_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
||
<p>Lumbar spine BMD</p>
|
||
<p>Distal radius BMD</p>
|
||
<p>Serious adverse events</p>
|
||
</td></tr><tr><td headers="hd_h_ch8.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Khan 2004<a class="bk_pop" href="#ch8.ref15"><sup>15</sup></a></td><td headers="hd_h_ch8.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Alendronate versus Placebo</td><td headers="hd_h_ch8.tab2_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
||
<p>Mix of men and women (≈ 1:3) with PHPT in which the majority (>60%) were osteoporotic (inclusion criteria was T score <−1.0 at ≥1 skeletal site)</p>
|
||
<p>Stratum analysed in: hypercalcaemic PHPT and presence of bone end-organ effects</p>
|
||
</td><td headers="hd_h_ch8.tab2_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">12 months</td><td headers="hd_h_ch8.tab2_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
||
<p>Fractures</p>
|
||
<p>Adverse events</p>
|
||
</td></tr></tbody></table></div></div></div><div class="whole_rhythm bk_prnt_obj"><div id="ch8.tab3" class="table"><h3><span class="label">Table 3</span><span class="title">Clinical evidence summary: Alendronate + Vitamin D versus Vitamin D only</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK577895/table/ch8.tab3/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__ch8.tab3_lrgtbl__"><table class="no_bottom_margin"><thead><tr><th id="hd_h_ch8.tab3_1_1_1_1" rowspan="2" colspan="1" headers="hd_h_ch8.tab3_1_1_1_1" style="text-align:left;vertical-align:bottom;">Outcomes</th><th id="hd_h_ch8.tab3_1_1_1_2" rowspan="2" colspan="1" headers="hd_h_ch8.tab3_1_1_1_2" style="text-align:left;vertical-align:bottom;">№ of participants (studies) Follow-up</th><th id="hd_h_ch8.tab3_1_1_1_3" rowspan="2" colspan="1" headers="hd_h_ch8.tab3_1_1_1_3" style="text-align:left;vertical-align:bottom;">Quality of the evidence (GRADE)</th><th id="hd_h_ch8.tab3_1_1_1_4" rowspan="2" colspan="1" headers="hd_h_ch8.tab3_1_1_1_4" style="text-align:left;vertical-align:bottom;">Relative effect (95% CI)</th><th id="hd_h_ch8.tab3_1_1_1_5" colspan="2" rowspan="1" style="text-align:left;vertical-align:bottom;">Anticipated absolute effects</th></tr><tr><th headers="hd_h_ch8.tab3_1_1_1_5" id="hd_h_ch8.tab3_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Risk with Vitamin D only</th><th headers="hd_h_ch8.tab3_1_1_1_5" id="hd_h_ch8.tab3_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Risk difference with Alendronate + Vitamin D</th></tr></thead><tbody><tr><td headers="hd_h_ch8.tab3_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
||
<p>Lumbar spine BMD assessed with: g/cm<sup>2</sup></p>
|
||
<p>follow up: 12 months</p>
|
||
</td><td headers="hd_h_ch8.tab3_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
||
<p>30</p>
|
||
<p>(1 RCT)</p>
|
||
</td><td headers="hd_h_ch8.tab3_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">LOW<sup><a class="bk_pop" href="#ch8.tab3_1">a</a></sup><sup>,</sup><sup><a class="bk_pop" href="#ch8.tab3_2">b</a></sup></td><td headers="hd_h_ch8.tab3_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">-</td><td headers="hd_h_ch8.tab3_1_1_1_5 hd_h_ch8.tab3_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">The mean lumbar spine BMD was 0.759 g/cm<sup>2</sup></td><td headers="hd_h_ch8.tab3_1_1_1_5 hd_h_ch8.tab3_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
||
<p>0.06 higher</p>
|
||
<p>(0.01 higher to 0.11 higher)</p>
|
||
</td></tr><tr><td headers="hd_h_ch8.tab3_1_1_1_1" rowspan="2" colspan="1" style="text-align:left;vertical-align:top;">
|
||
<p>Incidence of hypercalcaemia or hypercalciuria</p>
|
||
<p>follow up: 12 months</p>
|
||
</td><td headers="hd_h_ch8.tab3_1_1_1_2" rowspan="2" colspan="1" style="text-align:left;vertical-align:top;">
|
||
<p>30</p>
|
||
<p>(1 RCT)</p>
|
||
</td><td headers="hd_h_ch8.tab3_1_1_1_3" rowspan="2" colspan="1" style="text-align:left;vertical-align:top;">LOW<sup><a class="bk_pop" href="#ch8.tab3_1">a</a></sup><sup>,</sup><sup><a class="bk_pop" href="#ch8.tab3_3">c</a></sup></td><td headers="hd_h_ch8.tab3_1_1_1_4" rowspan="2" colspan="1" style="text-align:left;vertical-align:top;">Not estimable</td><td headers="hd_h_ch8.tab3_1_1_1_5 hd_h_ch8.tab3_1_1_2_1 hd_h_ch8.tab3_1_1_2_2" colspan="2" rowspan="1" style="text-align:left;vertical-align:top;">Moderate</td></tr><tr><td headers="hd_h_ch8.tab3_1_1_1_5 hd_h_ch8.tab3_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">0 per 1000</td><td headers="hd_h_ch8.tab3_1_1_1_5 hd_h_ch8.tab3_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
||
<p>0 fewer per 1000</p>
|
||
<p>(120 fewer to 120 more)</p>
|
||
</td></tr></tbody></table></div><div><div><dl class="temp-labeled-list small"><dt>a</dt><dd><div id="ch8.tab3_1"><p class="no_margin">Downgraded by one increment if the majority of the evidence was at high risk of bias and downgraded by two increments if the majority of the evidence was at very high risk of bias</p></div></dd><dt>b</dt><dd><div id="ch8.tab3_2"><p class="no_margin">Downgraded by one increment if the confidence interval crossed one MID, and downgraded by two increments if the confidence interval crossed both MIDs</p></div></dd><dt>c</dt><dd><div id="ch8.tab3_3"><p class="no_margin">Outcome of interest listed in the protocol is the number of persistent hypercalcaemia cases</p></div></dd></dl></div></div></div></div><div class="whole_rhythm bk_prnt_obj"><div id="ch8.tab4" class="table"><h3><span class="label">Table 4</span><span class="title">Clinical evidence summary: Alendronate versus Placebo</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK577895/table/ch8.tab4/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__ch8.tab4_lrgtbl__"><table class="no_bottom_margin"><thead><tr><th id="hd_h_ch8.tab4_1_1_1_1" rowspan="2" colspan="1" headers="hd_h_ch8.tab4_1_1_1_1" style="text-align:left;vertical-align:bottom;">Outcomes</th><th id="hd_h_ch8.tab4_1_1_1_2" rowspan="2" colspan="1" headers="hd_h_ch8.tab4_1_1_1_2" style="text-align:left;vertical-align:bottom;">№ of participants (studies) Follow-up</th><th id="hd_h_ch8.tab4_1_1_1_3" rowspan="2" colspan="1" headers="hd_h_ch8.tab4_1_1_1_3" style="text-align:left;vertical-align:bottom;">Quality of the evidence (GRADE)</th><th id="hd_h_ch8.tab4_1_1_1_4" rowspan="2" colspan="1" headers="hd_h_ch8.tab4_1_1_1_4" style="text-align:left;vertical-align:bottom;">Relative effect (95% CI)</th><th id="hd_h_ch8.tab4_1_1_1_5" colspan="2" rowspan="1" style="text-align:left;vertical-align:bottom;">Anticipated absolute effects</th></tr><tr><th headers="hd_h_ch8.tab4_1_1_1_5" id="hd_h_ch8.tab4_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Risk with Placebo</th><th headers="hd_h_ch8.tab4_1_1_1_5" id="hd_h_ch8.tab4_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Risk difference with Alendronate</th></tr></thead><tbody><tr><td headers="hd_h_ch8.tab4_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
||
<p>Lumbar spine BMD assessed with: % change from baseline</p>
|
||
<p>follow up: 48 weeks</p>
|
||
</td><td headers="hd_h_ch8.tab4_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
||
<p>40</p>
|
||
<p>(1 RCT)</p>
|
||
</td><td headers="hd_h_ch8.tab4_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">LOW<sup><a class="bk_pop" href="#ch8.tab4_1">a</a></sup></td><td headers="hd_h_ch8.tab4_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">-</td><td headers="hd_h_ch8.tab4_1_1_1_5 hd_h_ch8.tab4_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">The mean change in lumbar spine BMD was +0.19 %</td><td headers="hd_h_ch8.tab4_1_1_1_5 hd_h_ch8.tab4_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
||
<p>MD 3.6% higher</p>
|
||
<p>(1.45 higher to 5.75 higher)</p>
|
||
</td></tr><tr><td headers="hd_h_ch8.tab4_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
||
<p>Distal radius BMD assessed with: % change from baseline</p>
|
||
<p>follow up: 48 weeks</p>
|
||
</td><td headers="hd_h_ch8.tab4_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
||
<p>40</p>
|
||
<p>(1 RCT)</p>
|
||
</td><td headers="hd_h_ch8.tab4_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">VERY LOW<sup><a class="bk_pop" href="#ch8.tab4_1">a</a></sup><sup>,</sup><sup><a class="bk_pop" href="#ch8.tab4_2">b</a></sup></td><td headers="hd_h_ch8.tab4_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">-</td><td headers="hd_h_ch8.tab4_1_1_1_5 hd_h_ch8.tab4_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">The mean change in distal radius BMD was +0.07 %</td><td headers="hd_h_ch8.tab4_1_1_1_5 hd_h_ch8.tab4_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
||
<p>MD 0.94% higher</p>
|
||
<p>(1.68 lower to 3.56 higher)</p>
|
||
</td></tr><tr><td headers="hd_h_ch8.tab4_1_1_1_1" rowspan="2" colspan="1" style="text-align:left;vertical-align:top;">
|
||
<p>Number of serious adverse events</p>
|
||
<p>follow up: 48 weeks</p>
|
||
</td><td headers="hd_h_ch8.tab4_1_1_1_2" rowspan="2" colspan="1" style="text-align:left;vertical-align:top;">
|
||
<p>40</p>
|
||
<p>(1 RCT)</p>
|
||
</td><td headers="hd_h_ch8.tab4_1_1_1_3" rowspan="2" colspan="1" style="text-align:left;vertical-align:top;">VERY LOW<sup><a class="bk_pop" href="#ch8.tab4_1">a</a></sup><sup>,</sup><sup><a class="bk_pop" href="#ch8.tab4_2">b</a></sup></td><td headers="hd_h_ch8.tab4_1_1_1_4" rowspan="2" colspan="1" style="text-align:left;vertical-align:top;">
|
||
<p>RR 0.67</p>
|
||
<p>(0.12 to 3.57)</p>
|
||
</td><td headers="hd_h_ch8.tab4_1_1_1_5 hd_h_ch8.tab4_1_1_2_1 hd_h_ch8.tab4_1_1_2_2" colspan="2" rowspan="1" style="text-align:left;vertical-align:top;">Moderate</td></tr><tr><td headers="hd_h_ch8.tab4_1_1_1_5 hd_h_ch8.tab4_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">150 per 1000</td><td headers="hd_h_ch8.tab4_1_1_1_5 hd_h_ch8.tab4_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
||
<p>49 fewer per 1000</p>
|
||
<p>(132 fewer to 385 more)</p>
|
||
</td></tr><tr><td headers="hd_h_ch8.tab4_1_1_1_1" rowspan="2" colspan="1" style="text-align:left;vertical-align:top;">
|
||
<p>Number of fractures</p>
|
||
<p>follow up: 12 months</p>
|
||
</td><td headers="hd_h_ch8.tab4_1_1_1_2" rowspan="2" colspan="1" style="text-align:left;vertical-align:top;">
|
||
<p>37</p>
|
||
<p>(1 RCT)</p>
|
||
</td><td headers="hd_h_ch8.tab4_1_1_1_3" rowspan="2" colspan="1" style="text-align:left;vertical-align:top;">LOW<sup><a class="bk_pop" href="#ch8.tab4_1">a</a></sup></td><td headers="hd_h_ch8.tab4_1_1_1_4" rowspan="2" colspan="1" style="text-align:left;vertical-align:top;">Not estimable</td><td headers="hd_h_ch8.tab4_1_1_1_5 hd_h_ch8.tab4_1_1_2_1 hd_h_ch8.tab4_1_1_2_2" colspan="2" rowspan="1" style="text-align:left;vertical-align:top;">Moderate</td></tr><tr><td headers="hd_h_ch8.tab4_1_1_1_5 hd_h_ch8.tab4_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">0 per 1000</td><td headers="hd_h_ch8.tab4_1_1_1_5 hd_h_ch8.tab4_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
||
<p>0 fewer per 1000</p>
|
||
<p>(100 fewer to 100 more)</p>
|
||
</td></tr><tr><td headers="hd_h_ch8.tab4_1_1_1_1" rowspan="2" colspan="1" style="text-align:left;vertical-align:top;">
|
||
<p>Number of adverse events</p>
|
||
<p>follow up: 12 months</p>
|
||
</td><td headers="hd_h_ch8.tab4_1_1_1_2" rowspan="2" colspan="1" style="text-align:left;vertical-align:top;">
|
||
<p>37</p>
|
||
<p>(1 RCT)</p>
|
||
</td><td headers="hd_h_ch8.tab4_1_1_1_3" rowspan="2" colspan="1" style="text-align:left;vertical-align:top;">LOW<sup><a class="bk_pop" href="#ch8.tab4_1">a</a></sup></td><td headers="hd_h_ch8.tab4_1_1_1_4" rowspan="2" colspan="1" style="text-align:left;vertical-align:top;">Not estimable</td><td headers="hd_h_ch8.tab4_1_1_1_5 hd_h_ch8.tab4_1_1_2_1 hd_h_ch8.tab4_1_1_2_2" colspan="2" rowspan="1" style="text-align:left;vertical-align:top;">Moderate</td></tr><tr><td headers="hd_h_ch8.tab4_1_1_1_5 hd_h_ch8.tab4_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">0 per 1000</td><td headers="hd_h_ch8.tab4_1_1_1_5 hd_h_ch8.tab4_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
||
<p>0 fewer per 1000</p>
|
||
<p>(100 fewer to 100 more)</p>
|
||
</td></tr></tbody></table></div><div><div><dl class="temp-labeled-list small"><dt>a</dt><dd><div id="ch8.tab4_1"><p class="no_margin">Downgraded by one increment if the majority of the evidence was at high risk of bias and downgraded by two increments if the majority of the evidence was at very high risk of bias</p></div></dd><dt>b</dt><dd><div id="ch8.tab4_2"><p class="no_margin">Downgraded by one increment if the confidence interval crossed one MID, and downgraded by two increments if the confidence interval crossed both MIDs</p></div></dd></dl></div></div></div></div><div class="whole_rhythm bk_prnt_obj"><div id="ch8.tab5" class="table"><h3><span class="label">Table 5</span><span class="title">UK costs of bisphosphonates</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK577895/table/ch8.tab5/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__ch8.tab5_lrgtbl__"><table class="no_bottom_margin"><thead><tr><th id="hd_h_ch8.tab5_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:middle;">Drug</th><th id="hd_h_ch8.tab5_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:middle;">Preparation</th><th id="hd_h_ch8.tab5_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:middle;">Recommended dose</th><th id="hd_h_ch8.tab5_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:middle;">Cost – per month</th><th id="hd_h_ch8.tab5_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:middle;">Cost – annual</th></tr></thead><tbody><tr><td headers="hd_h_ch8.tab5_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:middle;">Alendronic acid</td><td headers="hd_h_ch8.tab5_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:middle;">Tablet</td><td headers="hd_h_ch8.tab5_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:middle;">70 mg weekly<sup><a class="bk_pop" href="#ch8.tab5_1">(a)</a></sup></td><td headers="hd_h_ch8.tab5_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:middle;">£0.60</td><td headers="hd_h_ch8.tab5_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:middle;">£7.82</td></tr><tr><td headers="hd_h_ch8.tab5_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:middle;">Zoledronic acid</td><td headers="hd_h_ch8.tab5_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:middle;">Intravenous infusion</td><td headers="hd_h_ch8.tab5_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:middle;">50 mcg/ml once a year</td><td headers="hd_h_ch8.tab5_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:middle;">-</td><td headers="hd_h_ch8.tab5_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:middle;">£13.24</td></tr></tbody></table></div><div><div><dl class="temp-labeled-list small"><dt></dt><dd><div><p class="no_margin">Source[s]: NHS Drug Tariff, 2017<a class="bk_pop" href="#ch8.ref19"><sup>19</sup></a>; BNF<a class="bk_pop" href="#ch8.ref11"><sup>11</sup></a>, eMIT<a class="bk_pop" href="#ch8.ref6"><sup>6</sup></a></p></div></dd><dt>(a)</dt><dd><div id="ch8.tab5_1"><p class="no_margin">Taken once per week as a single dose</p></div></dd></dl></div></div></div></div></div><div><p>Final</p></div><div><p>Intervention evidence review</p><p>This evidence review was developed by the National Guideline Centre</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></div>
|
||
<div class="post-content"><div><div class="half_rhythm"><a href="/books/about/copyright/">Copyright</a> © NICE 2019.</div><div class="small"><span class="label">Bookshelf ID: NBK577895</span><span class="label">PMID: <a href="https://pubmed.ncbi.nlm.nih.gov/35167211" title="PubMed record of this title" ref="pagearea=meta&targetsite=entrez&targetcat=link&targettype=pubmed">35167211</a></span></div></div></div>
|
||
|
||
</div>
|
||
</div>
|
||
</div>
|
||
<div class="bottom">
|
||
|
||
<div id="NCBIFooter_dynamic">
|
||
<!--<component id="Breadcrumbs" label="breadcrumbs"/>
|
||
<component id="Breadcrumbs" label="helpdesk"/>-->
|
||
|
||
</div>
|
||
|
||
<script type="text/javascript" src="/portal/portal3rc.fcgi/rlib/js/InstrumentNCBIBaseJS/InstrumentPageStarterJS.js"> </script>
|
||
</div>
|
||
</div>
|
||
<!--/.page-->
|
||
</div>
|
||
<!--/.wrap-->
|
||
</div><!-- /.twelve_col -->
|
||
</div>
|
||
<!-- /.grid -->
|
||
|
||
<span class="PAFAppResources"></span>
|
||
|
||
<!-- BESelector tab -->
|
||
|
||
|
||
|
||
<noscript><img alt="statistics" src="/stat?jsdisabled=true&ncbi_db=books&ncbi_pdid=book-toc&ncbi_acc=NBK577895&ncbi_domain=niceng132er8&ncbi_report=printable&ncbi_type=fulltext&ncbi_objectid=&ncbi_pcid=/NBK577895/?report=printable&ncbi_app=bookshelf" /></noscript>
|
||
|
||
|
||
<!-- usually for JS scripts at page bottom -->
|
||
<!--<component id="PageFixtures" label="styles"></component>-->
|
||
|
||
|
||
<!-- CE8B5AF87C7FFCB1_0191SID /projects/books/PBooks@9.11 portal107 v4.1.r689238 Tue, Oct 22 2024 16:10:51 -->
|
||
<span id="portal-csrf-token" style="display:none" data-token="CE8B5AF87C7FFCB1_0191SID"></span>
|
||
|
||
<script type="text/javascript" src="//static.pubmed.gov/portal/portal3rc.fcgi/4216699/js/3879255/4121861/3501987/4008961/3893018/3821238/3400083/3426610.js" snapshot="books"></script></body>
|
||
</html> |