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id="_NBK577894_"><span itemprop="name">Evidence review for calcimimetics</span></h1><div class="subtitle">Hyperparathyroidism (primary): diagnosis, assessment and initial management</div><p><b>Evidence review G</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 class="bkr_clear"></div></div><div id="ch7.s1"><h2 id="_ch7_s1_">1. Calcimimetics</h2><div id="ch7.s1.1"><h3>1.1. Review question: What is the clinical and cost effectiveness of calcimimetics in people with primary hyperparathyroidism?</h3></div><div id="ch7.s1.2"><h3>1.2. Introduction</h3><p>Primary hyperparathyroidism (PHPT) results in inappropriately excessive secretion of parathyroid hormone (PTH) from the parathyroid gland. High PTH levels trigger various physiological processes to increase the amount of calcium in the blood, classically causing levels to rise above normal (hypercalcaemia); both raised PTH and calcium are responsible for the features of PHPT. Two of the most important long-term consequences of PHPT include loss of bone mineral with increased risk of fractures and an increased risk of kidney stones.<a class="bibr" href="#ch7.ref26" rid="ch7.ref26"><sup>26</sup></a> Calcimimetics reduce serum levels of PTH and calcium through their effect on the calcium-sensing receptor on parathyroid cells; however they do not directly stop bone loss or kidney problems due to PHPT. Currently the use of calcimimetics in PHPT is limited to the control of serum calcium in patients with symptomatic hypercalcaemia where surgery is indicated, but is not performed or has been unsuccessful. The aim of this review is to explore the clinical and cost effectiveness of calcimimetics in all people with PHPT.</p></div><div id="ch7.s1.3"><h3>1.3. PICO table</h3><p>For full details see the review protocol in <a href="#ch7.appa">appendix A</a>.</p><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figch7tab1"><a href="/books/NBK577894/table/ch7.tab1/?report=objectonly" target="object" title="Table 1" class="img_link icnblk_img figpopup" rid-figpopup="figch7tab1" rid-ob="figobch7tab1"><img class="small-thumb" src="/books/NBK577894/table/ch7.tab1/?report=thumb" src-large="/books/NBK577894/table/ch7.tab1/?report=previmg" alt="Table 1. PICO characteristics of review question." /></a><div class="icnblk_cntnt"><h4 id="ch7.tab1"><a href="/books/NBK577894/table/ch7.tab1/?report=objectonly" target="object" rid-ob="figobch7tab1">Table 1</a></h4><p class="float-caption no_bottom_margin">PICO characteristics of review question. </p></div></div></div><div id="ch7.s1.4"><h3>1.4. Clinical evidence</h3><div id="ch7.s1.4.1"><h4>1.4.1. Included studies</h4><p>A search was conducted for randomised controlled trials assessing the effectiveness of oral calcimimetics (cinacalcet) for treatment of people with primary hyperparathyroidism. The calcimimetics were to be compared against the following: placebo, no treatment, bisphosphonates, surgery or combination treatment.</p><p>Three studies were included in the review.<a class="bibr" href="#ch7.ref10" rid="ch7.ref10"><sup>10</sup></a><sup>,</sup>
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<a class="bibr" href="#ch7.ref19" rid="ch7.ref19"><sup>19</sup></a><sup>,</sup>
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<a class="bibr" href="#ch7.ref25" rid="ch7.ref25"><sup>25</sup></a> These are summarised in <a class="figpopup" href="/books/NBK577894/table/ch7.tab2/?report=objectonly" target="object" rid-figpopup="figch7tab2" rid-ob="figobch7tab2">Table 2</a> below. Evidence from these studies is summarised in the clinical evidence summary below (<a class="figpopup" href="/books/NBK577894/table/ch7.tab3/?report=objectonly" target="object" rid-figpopup="figch7tab3" rid-ob="figobch7tab3">Table 3</a>). See also the study selection flow chart in <a href="#ch7.appc">appendix C</a>, study evidence tables in <a href="#ch7.appd">appendix D</a>, forest plots in <a href="#ch7.appe">appendix E</a> and GRADE tables in <a href="#ch7.appf">appendix F</a>.</p><p>All three studies compared oral cinacalcet tablets with placebo. All the participants in one of the studies<a class="bibr" href="#ch7.ref10" rid="ch7.ref10"><sup>10</sup></a> had met the criteria for parathyroid surgery but were unable to undergo parathyroidectomy. To be included, each participant had to have a diagnosis of primary hyperparathyroidism based on laboratory measurements of total corrected serum calcium of between 2.83 and 3.13 mmol/litre. In the other two studies, the minimum levels of serum calcium set for inclusion were lower (2.53 mmol/litre in Peacock 2005<a class="bibr" href="#ch7.ref19" rid="ch7.ref19"><sup>19</sup></a> and 2.62 mmol/litre in Shoback 2003<a class="bibr" href="#ch7.ref25" rid="ch7.ref25"><sup>25</sup></a>). The reference range for adjusted serum calcium is 2.2 to 2.6 mmol/litre. Therefore, all studies included people with hypercalcaemia and were analysed together. No studies were identified for the results strata of normocalcaemic PHPT, previous parathyroidectomy or pregnant women. No studies were identified reporting the protocol outcomes of deterioration in renal function, fractures, occurrence of kidney stone, cardiovascular events, or cancer incidence.</p></div><div id="ch7.s1.4.2"><h4>1.4.2. Excluded studies</h4><p>See the excluded studies list in <a href="#ch7.appi">appendix I</a>.</p></div><div id="ch7.s1.4.3"><h4>1.4.3. Summary of clinical studies included in the evidence review</h4><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figch7tab2"><a href="/books/NBK577894/table/ch7.tab2/?report=objectonly" target="object" title="Table 2" class="img_link icnblk_img figpopup" rid-figpopup="figch7tab2" rid-ob="figobch7tab2"><img class="small-thumb" src="/books/NBK577894/table/ch7.tab2/?report=thumb" src-large="/books/NBK577894/table/ch7.tab2/?report=previmg" alt="Table 2. Summary of studies included in the evidence review." /></a><div class="icnblk_cntnt"><h4 id="ch7.tab2"><a href="/books/NBK577894/table/ch7.tab2/?report=objectonly" target="object" rid-ob="figobch7tab2">Table 2</a></h4><p class="float-caption no_bottom_margin">Summary of studies included in the evidence review. </p></div></div><p>See <a href="#ch7.appd">appendix D</a> for full evidence tables.</p></div><div id="ch7.s1.4.4"><h4>1.4.4. Quality assessment of clinical studies included in the evidence review</h4><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figch7tab3"><a href="/books/NBK577894/table/ch7.tab3/?report=objectonly" target="object" title="Table 3" class="img_link icnblk_img figpopup" rid-figpopup="figch7tab3" rid-ob="figobch7tab3"><img class="small-thumb" src="/books/NBK577894/table/ch7.tab3/?report=thumb" src-large="/books/NBK577894/table/ch7.tab3/?report=previmg" alt="Table 3. Clinical evidence summary: cinacalcet versus placebo." /></a><div class="icnblk_cntnt"><h4 id="ch7.tab3"><a href="/books/NBK577894/table/ch7.tab3/?report=objectonly" target="object" rid-ob="figobch7tab3">Table 3</a></h4><p class="float-caption no_bottom_margin">Clinical evidence summary: cinacalcet versus placebo. </p></div></div></div></div><div id="ch7.s1.5"><h3>1.5. Economic evidence</h3><div id="ch7.s1.5.1"><h4>1.5.1. Included studies</h4><p>No relevant health economic studies were identified.</p></div><div id="ch7.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="#ch7.appg">appendix G</a>.</p></div><div id="ch7.s1.5.3"><h4>1.5.3. Unit costs</h4><p>The cost of cinacalcet was presented to the committee for consideration of cost effectiveness. Cinacalcet is the only calcimimetic currently available for the treatment of PHPT in the UK.</p><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figch7tab4"><a href="/books/NBK577894/table/ch7.tab4/?report=objectonly" target="object" title="Table 4" class="img_link icnblk_img figpopup" rid-figpopup="figch7tab4" rid-ob="figobch7tab4"><img class="small-thumb" src="/books/NBK577894/table/ch7.tab4/?report=thumb" src-large="/books/NBK577894/table/ch7.tab4/?report=previmg" alt="Table 4. Cost of cinacalcet." /></a><div class="icnblk_cntnt"><h4 id="ch7.tab4"><a href="/books/NBK577894/table/ch7.tab4/?report=objectonly" target="object" rid-ob="figobch7tab4">Table 4</a></h4><p class="float-caption no_bottom_margin">Cost of cinacalcet. </p></div></div></div><div id="ch7.s1.5.4"><h4>1.5.4. Economic considerations</h4><p>Due to a lack of economic evidence a simple estimate of the cost effectiveness of calcimimetics was undertaken. This was calculated with an assumed population of 1,000 patients who are given either cinacalcet or placebo, with the outcome measured by whether normocalcaemia is achieved. The absolute values for outcomes were taken from the clinical review to determine the number of people in each arm that would achieve normocalcaemia.</p><p>Utility values of 0.8 and 0.6 were applied to those achieving normocalcaemia and those who do not, respectively. Due to a lack of quality of life data for these populations, these were estimated based on the quality of life outcomes from the clinical review and with committee consideration and the difference in quality of life between the two health states was considered to be a generous estimate.</p><p>All people in the cinacalcet arm incurred the cost of treatment with cinacalcet. The cost of a pack of 28 tablets (30 mg per tablet) was £125.75. Assuming an average dose of 60 mg per day (30 mg twice daily), this will cost £3,278 per year. For simplicity the cost of placebo was assumed to be zero.</p><p>A time horizon of 6 months was used to maintain consistency with the length of time for the clinical outcome used. It was agreed that as the effectiveness of calcimimetics does not diminish over time, and will remain effective as long as it continues to be taken. Therefore 6 months was considered to be sufficient for the purpose of this calculation.</p><p>The analysis showed the ICER to be £31,105. This is not cost effective at the £20,000 per QALY threshold, but is borderline cost effective at the £30,000 per QALY threshold.</p><p>The incremental effectiveness of 0.2 is considered to be a generous estimate as it is unclear whether patients included in the studies are symptomatic, and if so, to what extent. People who are severely symptomatic prior to treatment are likely to experience a greater improvement in quality of life; therefore this utility gain could be reflective, further reducing the likelihood of cinacalcet being cost effective.</p></div></div><div id="ch7.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="ch7.s1.7"><h3>1.7. Evidence statements</h3><div id="ch7.s1.7.1"><h4>1.7.1. Clinical evidence statements</h4><div id="ch7.s1.7.1.1"><h5>1.7.1.1. Cinacalcet versus placebo</h5><p>There was a clinically important benefit of cinacalcet for achieving normocalcaemia (2 studies, n=145; Low quality); short-term adverse events < 6 months (1 study, n=22; follow up 22 days; Very Low quality); QOL (SF-36 physical component; SF-36 mental component; MOS-CF; PAS) (1 study, n=67; follow up 28 weeks; Very Low quality). There was a clinical harm of calcimimetics for the outcome of long-term adverse events ≥6 months (2 studies, n=145; follow up 24 to 28 weeks; Very Low quality). There was no difference between cinacalcet and placebo for Lumbar spine BMD Z-score; distal radius BMD Z-score (1 study, n=78; follow up 52 weeks; Very Low quality). There was no difference between cinacalcet and placebo for mortality and serious adverse events ≥6 months (1 study, n=67; follow up 28 weeks; Very Low quality). No evidence was identified for the outcomes of deterioration in renal function, fractures, occurrence of kidney stones, cardiovascular events or cancer incidence.</p></div><div id="ch7.s1.7.1.2"><h5>1.7.1.2. Calcimimetics versus surgery</h5><p>No evidence was identified</p></div><div id="ch7.s1.7.1.3"><h5>1.7.1.3. Calcimimetics versus bisphosphonates</h5><p>No evidence was identified</p></div><div id="ch7.s1.7.1.4"><h5>1.7.1.4. Calcimimetics versus combination treatment (calcimimetics and bisphosphonates)</h5><p>No evidence was identified</p></div></div><div id="ch7.s1.7.2"><h4>1.7.2. Health economic evidence statements</h4><p>No relevant economic evaluations were identified.</p></div></div><div id="ch7.s1.8"><h3>1.8. The committee’s discussion of the evidence</h3><div id="ch7.s1.8.1"><h4>1.8.1. Interpreting the evidence</h4><div id="ch7.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 renal function, fractures, kidney stones, persistent hypercalcaemia, bone mineral density (lumbar spine and/or distal radius), cardiovascular events, cancer incidence and adverse events. The committee was interested in cardiovascular and cancer outcomes, as there is some observational evidence to suggest that the risk of these future events is higher in untreated primary hyperparathyroidism.</p><p>No evidence was identified for the outcomes of deterioration in renal function, fractures, occurrence of kidney stones, cardiovascular events or cancer incidence.</p></div><div id="ch7.s1.8.1.2"><h5>1.8.1.2. The quality of the evidence</h5><p>There was evidence from 3 studies comparing cinacalcet versus placebo. Cinacalcet is an oral calcimimetic used in the management of primary hyperparathyroidism. No evidence was available for comparison of calcimimetics with surgery, bisphosphonates or combination treatment (calcimimetics and bisphosphonates).</p><p>For the comparison of cinacalcet with placebo, the majority of the evidence was of Very Low quality due to risk of bias and imprecision. This decreases our confidence in the estimate of effect of cinacalcet.</p><p>All studies included people with hypercalcaemia. No evidence was identified for the results strata of normocalcaemic primary hyperparathyroidism or pregnant women.</p></div><div id="ch7.s1.8.1.3"><h5>1.8.1.3. Benefits and harms</h5><p>Of the three included studies, two studies included patients with mild to moderately severe primary hyperparathyroidism (serum calcium 2.62 – 3.13 mmol/litre) and in one study all the participants had met the criteria for parathyroid surgery (total adjusted serum calcium ≥ 2.85 mmol/litre) but were unable to undergo parathyroidectomy. The committee discussed that the population in the latter study reflected the current licenced indications for cinacalcet in primary hyperparathyroidism. It is also the population considered in a recent NHS England clinical commissioning document for ‘Cinacalcet for complex primary hyperparathyroidism in adults’.<a class="bibr" href="#ch7.ref26" rid="ch7.ref26"><sup>26</sup></a></p><p>The evidence suggested that the clinical benefits of cinacalcet outweigh the harms. The committee noted the clinical benefit of cinacalcet for the outcomes of quality of life, achieving normocalcaemia, and short-term adverse events. There was a clinical harm of cinacalcet for the outcome of long-term adverse events. The evidence for mortality was only based on one event and the fatal event in the study was considered as unrelated to the intervention. For this reason, the committee did not consider the evidence for the critical outcome of mortality. No clinical difference was found for the outcomes of serious adverse events, BMD of the lumbar spine and the distal radius.</p><p>Evidence was also available from a small sub-set of the population who had undergone previous unsuccessful surgery. The committee noted that there was a clinical benefit of using cinacalcet for the achievement of normocalcaemia. No evidence was available for any other outcomes for this population.</p><p>Cinacalcet acts to decrease serum calcium and therefore the committee considered the largest benefit would be in people with an adjusted serum calcium level above the reference range. Therefore, most benefit will be achieved in people with a high serum calcium level and symptoms resulting from their hypercalcaemia. It would also lower the risk of end organ damage. The committee however noted that cinacalcet should be an option in people who are unable to undergo surgery only and not as an alternative to surgery, as parathyroidectomy is the only definitive treatment option in people with primary hyperparathyroidism without surgical contraindication. Cinacalcet does not directly stop bone loss or kidney problems due to primary hyperparathyroidism.</p><p>The committee from their experience discussed that there is a group of patients who will not undergo surgery either because of patient choice or because they are unsuitable for surgery. In such cases cinacalcet can decrease their serum calcium levels and avoid episodes of hypercalcaemic crisis. The committee also noted that there is a small group of patients who have primary hyperparathyroidism after single/multiple unsuccessful surgeries who tend to benefit from cinacalcet. Often there are very few other options for these people and they can report an improvement in general wellbeing. Hence the committee recommended that cinacalcet should be considered in these groups of people with primary hyperparathyroidism.</p><p>The committee agreed to make recommendations specifically for cinacalcet as the evidence was available only for this type of calcimimetic. They also considered that if another calcimimetic was to be available in the future for use in primary hyperparathyroidism, the criteria for its use may be different. Hence they agreed that these recommendations should be applicable to cinacalcet only.</p><p>The committee discussed the cut-off values for hypercalcaemia and use of cinacalcet. The clinical benefit in quality of life in this review was judged to be in people with an adjusted serum calcium level above 2.85 mmol/litre. Therefore, the cut-off was set at 2.85 mmol/litre for people with symptoms of hypercalcaemia. For the cut-off to define hypercalcaemia in the presence or absence of symptoms, the committee agreed from clinical experience that this should be set at above 3.0 mmol/litre, largely due to the increased risk of hypercalcaemic crises that may be seen with this degree of hypercalcaemia. In the absence of evidence, the committee was unable to make a recommendation for people with normocalcaemia.</p><p>The committee discussed that for people with an initial albumin-adjusted serum calcium level below 3.0 mmol/litre, continuation of treatment should be based on reduction in symptoms. For people with initial albumin-adjusted serum calcium level 3.0 mmol/litre or above, continuation of treatment should be based on either reduction in serum calcium or reduction in symptoms. This distinction was again made largely due to the increased risk of hypercalcaemic crises that may be seen with this degree of hypercalcaemia.</p><p>The committee noted that albumin-adjusted serum calcium level should be measured before initiation of cinacalcet treatment and within 1 week after starting treatment or adjusting the dose. It was recognised that the dose of cinacalcet may be titrated up to achieve optimum effect in lowering serum calcium and potentially improving patients’ symptoms. They agreed that albumin-adjusted serum calcium level should be measured every 2–3 months, as stated in the British National Formulary (BNF). The committee in accordance with the BNF view felt that continued biochemical monitoring should occur irrespective of symptoms. The committee from their experience stated that if there is any improvement and return to the adjusted serum calcium reference range with cinacalcet, treatment should be continued at the minimum effective dose to maintain that state, as discontinuation of the cinacalcet will lead to raised calcium and the symptoms are likely to return. If cinacalcet is deemed effective, it would become potentially chronic therapy.</p><p>The committee discussed from clinical experience that cinacalcet is unlikely to have a beneficial effect on bone disease or kidney stones, as they do not act directly to reduce calcium excretion or bone loss. Hence they agreed that there was no benefit in prescribing cinacalcet if there are symptoms of end organ damage.</p></div></div><div id="ch7.s1.8.2"><h4>1.8.2. Cost effectiveness and resource use</h4><p>No economic evidence was identified for this question.</p><p>Cinacalcet is the only calcimimetic currently licensed for PHPT in the UK. It is an expensive drug costing around £3,278 per patient per year, at an average dose of 60 mg per day (30 mg twice daily).</p><p>It was noted in the clinical review that there is a trade-off in cases where an intervention is more effective, and has more adverse events. However, the adverse events noted in the studies were nausea, headache, muscle spasm, and paresthesia. Such adverse events are not uncommon to many other pharmacological treatments, and the committee considered that the benefits of treatment outweigh the potential adverse events.</p><p>However, cinacalcet is an expensive treatment and the cost effectiveness of treatment for this population is highly uncertain.</p><p>A simple calculation using the outcome of those achieving normocalcaemia was undertaken to estimate cost effectiveness. The example assumed a population of 1000, with each subject given either cinacalcet or placebo, and outcomes are measured by whether normocalcaemia is achieved. The absolute values for outcomes were taken from the clinical review. Assumptions for utility values were 0.8 and 0.6 for those achieving normocalcaemia and those who do not, respectively. A time horizon of 6 months was used to maintain consistency with length of time for the clinical outcome used.</p><p>The committee discussed that patients usually take cinacalcet for more than 6 months, which was the maximum duration of some of the trials in the clinical review. However, given that cinacalcet continues to be effective as long as it is being taken, for the purpose of this calculation a 6-month time horizon is considered to be sufficient, as the ratio between cost and effectiveness is likely to remain proportional thereafter. Only the cost of cinacalcet (at 60 mg per day) was included; the cost of placebo was assumed to be zero.</p><p>The analysis outlined above generated an ICER of around £31,000. This is borderline cost effective at the higher NICE threshold. However, it should be noted that the incremental quality of life estimates of 0.2 between a normocalcaemic and non-normocalcaemic patient is considered generous. It is unclear if patients included in the studies are symptomatic and if so, to what extent. If the true quality of life difference was smaller, the ICER will be higher than that estimated above.</p><p>The committee noted that side effects from cinacalcet are also likely to affect quality of life. Where people experience side effects as a result of taking cinacalcet, their actual improvement in quality of life is likely to be lower than that estimated in the above calculations. Additionally, if such side effects require use of health care resources – for example hospitalisation – then the incremental cost of calcimimetics may potentially be higher than estimated above. However, as mentioned above the adverse events reported in the studies are unlikely to cause a significant disutility to patients or incur significant additional costs.</p><p>The committee also discussed that the above calculation does not account for changes in resource use for those receiving no treatment. The committee noted that the cost of no treatment would be higher in current practice due to the cost of rehydration as a result of hypercalcaemia, which often requires hospital admission for intravenous fluids to be delivered, and treatment for the symptoms and further consequences of hypercalcaemia. Furthermore, there is a potential for long-term reduction in resource use following successful treatment with calcimimetics due to reducing symptoms of hypercalcemia and a reduced number of blood tests and GP appointments, as well as preventing possible end organ disease such as renal stones and fragility fractures.</p><p>In addition, the committee noted that patients with untreated hypercalcaemia are at a higher risk of hypercalcaemic crisis. This requires urgent hospitalisation and consequently leads to very high levels of healthcare resource use, as well as a significant decrement in quality of life, along with a high risk of mortality. While it was indicated that this is a rare occurrence, the high associated costs, and decrement in QALYs from hypercalcaemic crisis increases the likelihood of cinacalcet being cost effective. Therefore, overall, this is likely to lower the incremental cost and QALY difference between drug and placebo, hence reducing the ICER, and making cinacalcet more likely to be cost effective.</p><p>Overall, the cost effectiveness of calcimimetics is highly uncertain, due to the Low quality clinical review evidence. However, the committee noted that for patients who are unable to have surgery, calcimimetics would likely be their last remaining option in managing primary hyperparathyroidism and controlling their hypercalcaemia and avoiding potentially serious events that incur high healthcare resource use. Hence, despite the fact that the cost effectiveness of calcimimetics is highly uncertain, they should still be considered for people where appropriate.</p><p>The committee noted that the recommendations made were in line with current practice according to NHS England clinical commissioning policy and therefore do not expect a significant resource impact.</p></div><div id="ch7.s1.8.3"><h4>1.8.3. Other factors the committee took into account</h4><p>The committee discussed that cinacalcet was granted a marketing authorisation initially for management of secondary hyperparathyroidism in renal failure and for management of hypercalcaemia in parathyroid carcinoma. It was later approved for use in patients with primary hyperparathyroidism, who meet hypercalcaemia criteria for parathyroidectomy but who refuse or cannot undergo surgery.<a class="bibr" href="#ch7.ref26" rid="ch7.ref26"><sup>26</sup></a></p><p>The lay members in the committee pointed out that there is concern among patients that cinacalcet is being offered as an alternative when surgery should be used. As cinacalcet treats the symptoms and not the cause, many patients are concerned about the long term consequences of primary hyperparathyroidism if the underlying cause is not treated.</p><p>The committee discussed whether a validated objective assessment of symptoms was necessary but it was decided that the potential benefit was minimal compared to the time it would take to administer a questionnaire. The committee noted that the number of people who cannot have surgery has reduced with advances in surgical practice and anaesthesia.</p><p>While the committee acknowledged that the cost-effectiveness of cinacalcet is unclear, in many cases intervention using cinacalcet is the only option available to patients who are unable to have surgery.</p></div></div></div><div id="ch7.rl.r1"><h2 id="_ch7_rl_r1_">References</h2><dl class="temp-labeled-list"><dl class="bkr_refwrap"><dt>1.</dt><dd><div class="bk_ref" id="ch7.ref1">Akbaba
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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></dl><dl class="bkr_refwrap"><dt>7.</dt><dd><div class="bk_ref" id="ch7.ref7">Hassani
|
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S, Braunstein
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GD, Seibel
|
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MJ, Brickman
|
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AS, Geola
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F, Pekary
|
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AE
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et al. Alendronate therapy of primary hyperparathyroidism. Endocrinologist. 2001; 11(6):459–64</div></dd></dl><dl class="bkr_refwrap"><dt>8.</dt><dd><div class="bk_ref" id="ch7.ref8">Horiuchi
|
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T, Onouchi
|
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T, Inoue
|
|
J, Shionoiri
|
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A, Hosoi
|
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T, Orimo
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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></dl><dl class="bkr_refwrap"><dt>9.</dt><dd><div class="bk_ref" id="ch7.ref9">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></dl><dl class="bkr_refwrap"><dt>10.</dt><dd><div class="bk_ref" id="ch7.ref10">Khan
|
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A, Bilezikian
|
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J, Bone
|
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H, Gurevich
|
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A, Lakatos
|
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P, Misiorowski
|
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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></dl><dl class="bkr_refwrap"><dt>11.</dt><dd><div class="bk_ref" id="ch7.ref11">Khan
|
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AA, Bilezikian
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JP, Bone
|
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HG, Gurevich
|
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A, Lakatos
|
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P, Misiorowski
|
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W
|
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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></dl><dl class="bkr_refwrap"><dt>12.</dt><dd><div class="bk_ref" id="ch7.ref12">Khan
|
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AA, Bilezikian
|
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JP, Kung
|
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A, Dubois
|
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SJ, Standish
|
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TI, Syed
|
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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></dl><dl class="bkr_refwrap"><dt>13.</dt><dd><div class="bk_ref" id="ch7.ref13">Khan
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AA, Bilezikian
|
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JP, Kung
|
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AW, Ahmed
|
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MM, Dubois
|
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SJ, Ho
|
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AY
|
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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></dl><dl class="bkr_refwrap"><dt>14.</dt><dd><div class="bk_ref" id="ch7.ref14">Martin
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M, Robbins
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S, Lu
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ZJ. Use of cinacalcet in patients with intractable primary hyperparathyroidism (PHPT): A UK budget impact analysis. Endocrine Abstracts. 2010; 20:P228</div></dd></dl><dl class="bkr_refwrap"><dt>15.</dt><dd><div class="bk_ref" id="ch7.ref15">Narayan
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R, Perkins
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RM, Berbano
|
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EP, Yuan
|
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CM, Neff
|
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RT, Sawyers
|
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ES
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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></dl><dl class="bkr_refwrap"><dt>16.</dt><dd><div class="bk_ref" id="ch7.ref16">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></dl><dl class="bkr_refwrap"><dt>17.</dt><dd><div class="bk_ref" id="ch7.ref17">Parker
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CR, Blackwell
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PJ, Fairbairn
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KJ, Hosking
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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></dl><dl class="bkr_refwrap"><dt>18.</dt><dd><div class="bk_ref" id="ch7.ref18">Peacock
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M, Bilezikian
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JP, Bolognese
|
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MA, Borofsky
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M, Scumpia
|
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S, Sterling
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LR
|
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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></dl><dl class="bkr_refwrap"><dt>19.</dt><dd><div class="bk_ref" id="ch7.ref19">Peacock
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M, Bilezikian
|
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JP, Klassen
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PS, Guo
|
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MD, Turner
|
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SA, Shoback
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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></dl><dl class="bkr_refwrap"><dt>20.</dt><dd><div class="bk_ref" id="ch7.ref20">Peacock
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M, Bolognese
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MA, Borofsky
|
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M, Scumpia
|
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S, Sterling
|
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LR, Cheng
|
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S
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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></dl><dl class="bkr_refwrap"><dt>21.</dt><dd><div class="bk_ref" id="ch7.ref21">Reasner
|
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CA, Stone
|
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MD, Hosking
|
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DJ, Ballah
|
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A, Mundy
|
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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></dl><dl class="bkr_refwrap"><dt>22.</dt><dd><div class="bk_ref" id="ch7.ref22">Rossini
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M, Gatti
|
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D, Isaia
|
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G, Sartori
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L, Braga
|
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V, Adami
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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></dl><dl class="bkr_refwrap"><dt>23.</dt><dd><div class="bk_ref" id="ch7.ref23">Sankaran
|
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S, Gamble
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G, Bolland
|
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M, Reid
|
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IR, Grey
|
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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></dl><dl class="bkr_refwrap"><dt>24.</dt><dd><div class="bk_ref" id="ch7.ref24">Schwarz
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P, Body
|
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JJ, Cap
|
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J, Hofbauer
|
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LC, Farouk
|
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M, Gessl
|
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A
|
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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></dl><dl class="bkr_refwrap"><dt>25.</dt><dd><div class="bk_ref" id="ch7.ref25">Shoback
|
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DM, Bilezikian
|
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JP, Turner
|
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SA, McCary
|
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LC, Guo
|
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MD, Peacock
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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></dl><dl class="bkr_refwrap"><dt>26.</dt><dd><div class="bk_ref" id="ch7.ref26">Specialised Commissioning Team. Clinical Commissioning Policy: Cinacalcet for complex primary hyperparathyroidism in adults. NHS England, 2016. Available from: <a href="https://www.england.nhs.uk/wp-content/uploads/2017/06/ccp-cinacalcet-complex-primary-hyperparathyroidism-adults.pdf" ref="pagearea=cite-ref&targetsite=external&targetcat=link&targettype=uri">https://www<wbr style="display:inline-block"></wbr>​.england.nhs<wbr style="display:inline-block"></wbr>​.uk/wp-content/uploads<wbr style="display:inline-block"></wbr>​/2017/06/ccp-cinacalcet-complex-primary-hyperparathyroidism-adults.pdf</a></div></dd></dl><dl class="bkr_refwrap"><dt>27.</dt><dd><div class="bk_ref" id="ch7.ref27">Szczech
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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></dl></div><div id="appendixesappgroup7"><h2 id="_appendixesappgroup7_">Appendices</h2><div id="ch7.appa"><h3>Appendix A. Review protocols</h3><p id="ch7.appa.tab1"><a href="/books/NBK577894/table/ch7.appa.tab1/?report=objectonly" target="object" rid-ob="figobch7appatab1" class="figpopup">Table 5. Review protocol: Calcimimetics</a></p><p id="ch7.appa.tab2"><a href="/books/NBK577894/table/ch7.appa.tab2/?report=objectonly" target="object" rid-ob="figobch7appatab2" class="figpopup">Table 6. Health economic review protocol</a></p></div><div id="ch7.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="ch7.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 therefore difficult to retrieve. Search filters were applied to the search where appropriate.</p><p id="ch7.appb.tab1"><a href="/books/NBK577894/table/ch7.appb.tab1/?report=objectonly" target="object" rid-ob="figobch7appbtab1" class="figpopup">Table 7. Database date parameters and filters used</a></p><p id="ch7.appb.tab2"><a href="/books/NBK577894/table/ch7.appb.tab2/?report=objectonly" target="object" rid-ob="figobch7appbtab2" class="figpopup">Medline (Ovid) search terms</a></p><p id="ch7.appb.tab3"><a href="/books/NBK577894/table/ch7.appb.tab3/?report=objectonly" target="object" rid-ob="figobch7appbtab3" class="figpopup">Embase (Ovid) search terms</a></p><p id="ch7.appb.tab4"><a href="/books/NBK577894/table/ch7.appb.tab4/?report=objectonly" target="object" rid-ob="figobch7appbtab4" class="figpopup">Cochrane Library (Wiley) search terms</a></p><p id="ch7.appb.tab5"><a href="/books/NBK577894/table/ch7.appb.tab5/?report=objectonly" target="object" rid-ob="figobch7appbtab5" class="figpopup">CINAHL (EBSCO) search terms</a></p><p id="ch7.appb.tab6"><a href="/books/NBK577894/table/ch7.appb.tab6/?report=objectonly" target="object" rid-ob="figobch7appbtab6" class="figpopup">PsycINFO (ProQuest) search terms</a></p></div><div id="ch7.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><p id="ch7.appb.tab7"><a href="/books/NBK577894/table/ch7.appb.tab7/?report=objectonly" target="object" rid-ob="figobch7appbtab7" class="figpopup">Table 8. Database date parameters and filters used</a></p><p id="ch7.appb.tab8"><a href="/books/NBK577894/table/ch7.appb.tab8/?report=objectonly" target="object" rid-ob="figobch7appbtab8" class="figpopup">Medline (Ovid) search terms</a></p><p id="ch7.appb.tab9"><a href="/books/NBK577894/table/ch7.appb.tab9/?report=objectonly" target="object" rid-ob="figobch7appbtab9" class="figpopup">Embase (Ovid) search terms</a></p><p id="ch7.appb.tab10"><a href="/books/NBK577894/table/ch7.appb.tab10/?report=objectonly" target="object" rid-ob="figobch7appbtab10" class="figpopup">NHS EED and HTA (CRD) search terms</a></p></div></div><div id="ch7.appc"><h3>Appendix C. Clinical evidence selection</h3><p id="ch7.appc.fig1"><a href="/books/NBK577894/figure/ch7.appc.fig1/?report=objectonly" target="object" rid-ob="figobch7appcfig1" class="figpopup">Figure 1. Flow chart of clinical study selection for the review of pharmacological management (sifted for both calcimimetics and bisphosphonates reviews)</a></p></div><div id="ch7.appd"><h3>Appendix D. Clinical evidence tables</h3><p id="ch7.appd.et1"><a href="/books/NBK577894/bin/ch7-appd-et1.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Download PDF</a><span class="small"> (210K)</span></p></div><div id="ch7.appe"><h3>Appendix E. Forest plots</h3><div id="ch7.appe.s1"><h4>E.1. Cinacalcet versus placebo in primary hyperparathyroidism</h4><p id="ch7.appe.fig1"><a href="/books/NBK577894/figure/ch7.appe.fig1/?report=objectonly" target="object" rid-ob="figobch7appefig1" class="figpopup">Figure 2. SF-36 physical component</a></p><p id="ch7.appe.fig2"><a href="/books/NBK577894/figure/ch7.appe.fig2/?report=objectonly" target="object" rid-ob="figobch7appefig2" class="figpopup">Figure 3. SF-36 mental component</a></p><p id="ch7.appe.fig3"><a href="/books/NBK577894/figure/ch7.appe.fig3/?report=objectonly" target="object" rid-ob="figobch7appefig3" class="figpopup">Figure 4. MOS-CF scores</a></p><p id="ch7.appe.fig4"><a href="/books/NBK577894/figure/ch7.appe.fig4/?report=objectonly" target="object" rid-ob="figobch7appefig4" class="figpopup">Figure 5. PAS scores</a></p><p id="ch7.appe.fig5"><a href="/books/NBK577894/figure/ch7.appe.fig5/?report=objectonly" target="object" rid-ob="figobch7appefig5" class="figpopup">Figure 6. Mortality</a></p><p id="ch7.appe.fig6"><a href="/books/NBK577894/figure/ch7.appe.fig6/?report=objectonly" target="object" rid-ob="figobch7appefig6" class="figpopup">Figure 7. Achieving normocalcaemia</a></p><p id="ch7.appe.fig7"><a href="/books/NBK577894/figure/ch7.appe.fig7/?report=objectonly" target="object" rid-ob="figobch7appefig7" class="figpopup">Figure 8. Lumbar spine BMD Z-score</a></p><p id="ch7.appe.fig8"><a href="/books/NBK577894/figure/ch7.appe.fig8/?report=objectonly" target="object" rid-ob="figobch7appefig8" class="figpopup">Figure 9. Distal radius BMD Z-score</a></p><p id="ch7.appe.fig9"><a href="/books/NBK577894/figure/ch7.appe.fig9/?report=objectonly" target="object" rid-ob="figobch7appefig9" class="figpopup">Figure 10. Adverse events at <6 months</a></p><p id="ch7.appe.fig10"><a href="/books/NBK577894/figure/ch7.appe.fig10/?report=objectonly" target="object" rid-ob="figobch7appefig10" class="figpopup">Figure 11. Adverse events at ≥6 months</a></p><p id="ch7.appe.fig11"><a href="/books/NBK577894/figure/ch7.appe.fig11/?report=objectonly" target="object" rid-ob="figobch7appefig11" class="figpopup">Figure 12. Serious adverse events</a></p></div></div><div id="ch7.appf"><h3>Appendix F. GRADE tables</h3><p id="ch7.appf.tab1"><a href="/books/NBK577894/table/ch7.appf.tab1/?report=objectonly" target="object" rid-ob="figobch7appftab1" class="figpopup">Table 9. Clinical evidence profile: Cinacalcet versus placebo</a></p></div><div id="ch7.appg"><h3>Appendix G. Health economic evidence selection</h3><p id="ch7.appg.fig1"><a href="/books/NBK577894/figure/ch7.appg.fig1/?report=objectonly" target="object" rid-ob="figobch7appgfig1" class="figpopup">Figure 13. Flow chart of health economic study selection for the guideline</a></p></div><div id="ch7.apph"><h3>Appendix H. Health economic evidence tables</h3><p>No relevant health economic studies were identified.</p></div><div id="ch7.appi"><h3>Appendix I. Excluded studies</h3><div id="ch7.appi.s1"><h4>I.1. Excluded clinical studies</h4><p id="ch7.appi.tab1"><a href="/books/NBK577894/table/ch7.appi.tab1/?report=objectonly" target="object" rid-ob="figobch7appitab1" class="figpopup">Table 10. Studies excluded from the clinical review</a></p></div><div id="ch7.appi.s2"><h4>I.2. Excluded health economic studies</h4><p>None.</p></div></div></div></div><div class="fm-sec"><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 class="half_rhythm"><a href="/books/about/copyright/">Copyright</a> © NICE 2019.</div><div class="small"><span class="label">Bookshelf ID: NBK577894</span><span class="label">PMID: <a href="https://pubmed.ncbi.nlm.nih.gov/35167220" title="PubMed record of this title" ref="pagearea=meta&targetsite=entrez&targetcat=link&targettype=pubmed">35167220</a></span></div></div><div class="small-screen-prev"></div><div class="small-screen-next"></div></article><article data-type="table-wrap" id="figobch7tab1"><div id="ch7.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/NBK577894/table/ch7.tab1/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__ch7.tab1_lrgtbl__"><table><tbody><tr><th id="hd_b_ch7.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Population</th><td headers="hd_b_ch7.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>Adults (18 years or over) with confirmed primary hyperparathyroidism</p>
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<p>Strata (the following groups are reported separately):
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<ul id="ch7.l1"><li id="ch7.lt1" class="half_rhythm"><div>People with normocalcaemic PHPT</div></li><li id="ch7.lt2" class="half_rhythm"><div>Previous parathyroidectomy</div></li><li id="ch7.lt3" class="half_rhythm"><div>Pregnant women</div></li></ul></p>
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</td></tr><tr><th id="hd_b_ch7.tab1_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Interventions</th><td headers="hd_b_ch7.tab1_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Oral calcimimetics (cinacalcet)</td></tr><tr><th id="hd_b_ch7.tab1_1_1_3_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Comparisons</th><td headers="hd_b_ch7.tab1_1_1_3_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>Placebo</p>
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<p>No treatment</p>
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<p>Bisphosphonates</p>
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<p>Surgery</p>
|
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<p>Combination treatment (calcimimetics and bisphosphonates)</p>
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</td></tr><tr><th id="hd_b_ch7.tab1_1_1_4_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Outcomes</th><td headers="hd_b_ch7.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; bone mineral density (lumbar spine and/or distal radius); cardiovascular events; adverse events; cancer incidence</td></tr><tr><th id="hd_b_ch7.tab1_1_1_5_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Study design</th><td headers="hd_b_ch7.tab1_1_1_5_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">RCTs and systematic reviews of RCTs (non-randomised studies will only be included in the absence of RCTs)</td></tr></tbody></table></div></div></article><article data-type="table-wrap" id="figobch7tab2"><div id="ch7.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/NBK577894/table/ch7.tab2/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__ch7.tab2_lrgtbl__"><table class="no_bottom_margin"><thead><tr><th id="hd_h_ch7.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Study</th><th id="hd_h_ch7.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Intervention and comparison</th><th id="hd_h_ch7.tab2_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Population</th><th id="hd_h_ch7.tab2_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Follow-up</th><th id="hd_h_ch7.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_ch7.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Khan 2015<a class="bibr" href="#ch7.ref10" rid="ch7.ref10"><sup>10</sup></a></td><td headers="hd_h_ch7.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Cinacalcet versus placebo</td><td headers="hd_h_ch7.tab2_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">n=67
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<ul id="ch7.l2"><li id="ch7.lt4" class="half_rhythm"><div>People with PHPT who met the criteria for parathyroid surgery but were unable to undergo parathyroidectomy</div></li><li id="ch7.lt5" class="half_rhythm"><div>Total corrected serum calcium ≥ 2.85 mmol/L</div></li></ul></td><td headers="hd_h_ch7.tab2_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">28 weeks</td><td headers="hd_h_ch7.tab2_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<ul id="ch7.l3"><li id="ch7.lt6" class="half_rhythm"><div>Health-related quality of life (PAS, MOS-CF, SF-36)</div></li><li id="ch7.lt7" class="half_rhythm"><div>Mortality</div></li><li id="ch7.lt8" class="half_rhythm"><div>Proportion of participants achieving normocalcaemia (corrected total serum calcium ≤2.575 mmol/L)</div></li><li id="ch7.lt9" class="half_rhythm"><div>Treatment-associated adverse events</div></li><li id="ch7.lt10" class="half_rhythm"><div>Serious adverse events</div></li></ul></td></tr><tr><td headers="hd_h_ch7.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Peacock 2005<a class="bibr" href="#ch7.ref19" rid="ch7.ref19"><sup>19</sup></a></td><td headers="hd_h_ch7.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Cinacalcet versus placebo</td><td headers="hd_h_ch7.tab2_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">n=78
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<ul id="ch7.l4"><li id="ch7.lt11" class="half_rhythm"><div>Mild to moderate PHPT with disease severity ranging from asymptomatic to symptomatic</div></li><li id="ch7.lt12" class="half_rhythm"><div>23% with history of unsuccessful parathyroidectomy</div></li><li id="ch7.lt13" class="half_rhythm"><div>Serum calcium 2.57–3.12 mmol/L</div></li></ul></td><td headers="hd_h_ch7.tab2_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">24 & 52 weeks</td><td headers="hd_h_ch7.tab2_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<ul id="ch7.l5"><li id="ch7.lt14" class="half_rhythm"><div>Proportion of participants achieving normocalcaemia (serum calcium ≤2.57 mmol/L) with a minimum of 0.12 mmol/L reduction from baseline (follow-up 24 weeks)</div></li><li id="ch7.lt15" class="half_rhythm"><div>Lumbar and distal radius BMDs (follow-up 52 weeks)</div></li><li id="ch7.lt16" class="half_rhythm"><div>Withdrawals due to adverse events (follow-up 52 weeks)</div></li></ul>
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Data for people with unsuccessful surgery has been analysed in the failed surgery evidence review.</td></tr><tr><td headers="hd_h_ch7.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Shoback 2003<a class="bibr" href="#ch7.ref25" rid="ch7.ref25"><sup>25</sup></a></td><td headers="hd_h_ch7.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Cinacalcet versus placebo</td><td headers="hd_h_ch7.tab2_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">n=22
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<ul id="ch7.l6"><li id="ch7.lt17" class="half_rhythm"><div>Mild to moderate PHPT with disease severity ranging from asymptomatic to symptomatic</div></li><li id="ch7.lt18" class="half_rhythm"><div>18% with history of unsuccessful parathyroidectomy</div></li><li id="ch7.lt19" class="half_rhythm"><div>Serum calcium 2.62 – 3.13 mmol/L</div></li></ul></td><td headers="hd_h_ch7.tab2_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">22 days</td><td headers="hd_h_ch7.tab2_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<ul id="ch7.l7"><li id="ch7.lt20" class="half_rhythm"><div>Adverse events</div></li></ul></td></tr></tbody></table></div><div class="tblwrap-foot"><div><dl class="temp-labeled-list small"><dl class="bkr_refwrap"><dt></dt><dd><div><p class="no_margin">PAS = Parathyroid assessment of symptoms; MOS-CF = Medical outcomes study – cognitive functioning; SF-36 = Short-form 36 questionnaire</p></div></dd></dl></dl></div></div></div></article><article data-type="table-wrap" id="figobch7tab3"><div id="ch7.tab3" class="table"><h3><span class="label">Table 3</span><span class="title">Clinical evidence summary: cinacalcet versus placebo</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK577894/table/ch7.tab3/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__ch7.tab3_lrgtbl__"><table class="no_bottom_margin"><thead><tr><th id="hd_h_ch7.tab3_1_1_1_1" rowspan="2" colspan="1" headers="hd_h_ch7.tab3_1_1_1_1" style="text-align:left;vertical-align:bottom;">Outcomes</th><th id="hd_h_ch7.tab3_1_1_1_2" rowspan="2" colspan="1" headers="hd_h_ch7.tab3_1_1_1_2" style="text-align:left;vertical-align:bottom;">№ of participants (studies) Follow-up</th><th id="hd_h_ch7.tab3_1_1_1_3" rowspan="2" colspan="1" headers="hd_h_ch7.tab3_1_1_1_3" style="text-align:left;vertical-align:bottom;">Quality of the evidence (GRADE)</th><th id="hd_h_ch7.tab3_1_1_1_4" rowspan="2" colspan="1" headers="hd_h_ch7.tab3_1_1_1_4" style="text-align:left;vertical-align:bottom;">Relative effect (95% CI)</th><th id="hd_h_ch7.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_ch7.tab3_1_1_1_5" id="hd_h_ch7.tab3_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Risk with Placebo</th><th headers="hd_h_ch7.tab3_1_1_1_5" id="hd_h_ch7.tab3_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Risk difference with Cinacalcet</th></tr></thead><tbody><tr><td headers="hd_h_ch7.tab3_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
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<p>QOL SF-36 physical component</p>
|
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<p>Scale from: 0 to 100</p>
|
|
<p>follow up: 28 weeks</p>
|
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</td><td headers="hd_h_ch7.tab3_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
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<p>67</p>
|
|
<p>(1 RCT)</p>
|
|
</td><td headers="hd_h_ch7.tab3_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">VERY LOW<sup>a</sup><sup>,</sup><sup>b</sup><sup>,</sup><sup>c</sup></td><td headers="hd_h_ch7.tab3_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">-</td><td headers="hd_h_ch7.tab3_1_1_1_5 hd_h_ch7.tab3_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">The mean change in SF-36 physical component was 0.4</td><td headers="hd_h_ch7.tab3_1_1_1_5 hd_h_ch7.tab3_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>MD 2.9 higher mean change score</p>
|
|
<p>(0.29 lower to 6.09 higher)</p>
|
|
</td></tr><tr><td headers="hd_h_ch7.tab3_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
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<p>QOL SF-36 mental component</p>
|
|
<p>Scale from: 0 to 100</p>
|
|
<p>follow up: 28 weeks</p>
|
|
</td><td headers="hd_h_ch7.tab3_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
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<p>67</p>
|
|
<p>(1 RCT)</p>
|
|
</td><td headers="hd_h_ch7.tab3_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">VERY LOW<sup>a</sup><sup>,</sup><sup>b</sup><sup>,</sup><sup>c</sup></td><td headers="hd_h_ch7.tab3_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">-</td><td headers="hd_h_ch7.tab3_1_1_1_5 hd_h_ch7.tab3_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">The mean change in SF-36 mental component was −2.7</td><td headers="hd_h_ch7.tab3_1_1_1_5 hd_h_ch7.tab3_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>MD 4.3 higher mean change score</p>
|
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<p>(0 to 8.6 higher)</p>
|
|
</td></tr><tr><td headers="hd_h_ch7.tab3_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
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<p>QOL MOS-CF</p>
|
|
<p>Scale from: 0 to 100</p>
|
|
<p>follow up: 28 weeks</p>
|
|
</td><td headers="hd_h_ch7.tab3_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
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<p>67</p>
|
|
<p>(1 RCT)</p>
|
|
</td><td headers="hd_h_ch7.tab3_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">VERY LOW<sup>a</sup><sup>,</sup><sup>b</sup></td><td headers="hd_h_ch7.tab3_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">-</td><td headers="hd_h_ch7.tab3_1_1_1_5 hd_h_ch7.tab3_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">The mean change in MOS-CF was −1.6</td><td headers="hd_h_ch7.tab3_1_1_1_5 hd_h_ch7.tab3_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>MD 8.7 higher mean change score</p>
|
|
<p>(0.59 lower to 17.99 higher)</p>
|
|
</td></tr><tr><td headers="hd_h_ch7.tab3_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>QOL PAS</p>
|
|
<p>Scale from: 0 to 1300</p>
|
|
<p>follow up: 28 weeks</p>
|
|
</td><td headers="hd_h_ch7.tab3_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>67</p>
|
|
<p>(1 RCT)</p>
|
|
</td><td headers="hd_h_ch7.tab3_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">VERY LOW<sup>a</sup><sup>,</sup><sup>b</sup></td><td headers="hd_h_ch7.tab3_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">-</td><td headers="hd_h_ch7.tab3_1_1_1_5 hd_h_ch7.tab3_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">The mean change in PAS was −59</td><td headers="hd_h_ch7.tab3_1_1_1_5 hd_h_ch7.tab3_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>MD 32 lower mean change score</p>
|
|
<p>(132.23 lower to 68.23 higher)</p>
|
|
</td></tr><tr><td headers="hd_h_ch7.tab3_1_1_1_1" rowspan="2" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Mortality</p>
|
|
<p>follow up: 28 weeks<sup>d</sup></p>
|
|
</td><td headers="hd_h_ch7.tab3_1_1_1_2" rowspan="2" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>67</p>
|
|
<p>(1 RCT)</p>
|
|
</td><td headers="hd_h_ch7.tab3_1_1_1_3" rowspan="2" colspan="1" style="text-align:left;vertical-align:top;">VERY LOW<sup>a</sup><sup>,</sup><sup>b</sup></td><td headers="hd_h_ch7.tab3_1_1_1_4" rowspan="2" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Peto OR 7.62</p>
|
|
<p>(0.15 to 384.01)</p>
|
|
</td><td headers="hd_h_ch7.tab3_1_1_1_5 hd_h_ch7.tab3_1_1_2_1 hd_h_ch7.tab3_1_1_2_2" colspan="2" rowspan="1" style="text-align:left;vertical-align:top;">Moderate</td></tr><tr><td headers="hd_h_ch7.tab3_1_1_1_5 hd_h_ch7.tab3_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">0 per 1,000</td><td headers="hd_h_ch7.tab3_1_1_1_5 hd_h_ch7.tab3_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>30 more per 1,000</p>
|
|
<p>(50 fewer to 110 more)</p>
|
|
</td></tr><tr><td headers="hd_h_ch7.tab3_1_1_1_1" rowspan="2" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Achieving normocalcaemia</p>
|
|
<p>follow up: range 24 weeks to 28 weeks</p>
|
|
</td><td headers="hd_h_ch7.tab3_1_1_1_2" rowspan="2" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>145</p>
|
|
<p>(2 RCTs)</p>
|
|
</td><td headers="hd_h_ch7.tab3_1_1_1_3" rowspan="2" colspan="1" style="text-align:left;vertical-align:top;">LOW <sup>a</sup></td><td headers="hd_h_ch7.tab3_1_1_1_4" rowspan="2" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 21.28</p>
|
|
<p>(6.29 to 71.99)</p>
|
|
</td><td headers="hd_h_ch7.tab3_1_1_1_5 hd_h_ch7.tab3_1_1_2_1 hd_h_ch7.tab3_1_1_2_2" colspan="2" rowspan="1" style="text-align:left;vertical-align:top;">Moderate</td></tr><tr><td headers="hd_h_ch7.tab3_1_1_1_5 hd_h_ch7.tab3_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">26 per 1,000</td><td headers="hd_h_ch7.tab3_1_1_1_5 hd_h_ch7.tab3_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>527 more per 1,000</p>
|
|
<p>(138 more to 1000 more)</p>
|
|
</td></tr><tr><td headers="hd_h_ch7.tab3_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Lumbar spine BMD Z-score</p>
|
|
<p>follow up: 52 weeks</p>
|
|
</td><td headers="hd_h_ch7.tab3_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>78</p>
|
|
<p>(1 RCT)</p>
|
|
</td><td headers="hd_h_ch7.tab3_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>VERY LOW<sup>a</sup><sup>,</sup><sup>b</sup></p>
|
|
</td><td headers="hd_h_ch7.tab3_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">-</td><td headers="hd_h_ch7.tab3_1_1_1_5 hd_h_ch7.tab3_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">The mean change in lumbar spine BMD Z-score was 0.03</td><td headers="hd_h_ch7.tab3_1_1_1_5 hd_h_ch7.tab3_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
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<p>MD 0.03 lower mean change score</p>
|
|
<p>(0.14 lower to 0.08 higher)</p>
|
|
</td></tr><tr><td headers="hd_h_ch7.tab3_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
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<p>Distal radius BMD Z-score</p>
|
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<p>follow up: 52 weeks</p>
|
|
</td><td headers="hd_h_ch7.tab3_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>78</p>
|
|
<p>(1 RCT)</p>
|
|
</td><td headers="hd_h_ch7.tab3_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>VERY LOW<sup>a</sup><sup>,</sup><sup>b</sup></p>
|
|
</td><td headers="hd_h_ch7.tab3_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">-</td><td headers="hd_h_ch7.tab3_1_1_1_5 hd_h_ch7.tab3_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">The mean change in distal radius BMD Z-score was −0.01</td><td headers="hd_h_ch7.tab3_1_1_1_5 hd_h_ch7.tab3_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>MD 0.04 lower mean change score</p>
|
|
<p>(0.19 lower to 0.11 higher)</p>
|
|
</td></tr><tr><td headers="hd_h_ch7.tab3_1_1_1_1" rowspan="2" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Adverse events at <6 months</p>
|
|
<p>follow up: 22 days</p>
|
|
</td><td headers="hd_h_ch7.tab3_1_1_1_2" rowspan="2" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>22</p>
|
|
<p>(1 RCT)</p>
|
|
</td><td headers="hd_h_ch7.tab3_1_1_1_3" rowspan="2" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>VERY LOW<sup>a</sup><sup>,</sup><sup>b</sup></p>
|
|
</td><td headers="hd_h_ch7.tab3_1_1_1_4" rowspan="2" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 0.84</p>
|
|
<p>(0.41 to 1.72)</p>
|
|
</td><td headers="hd_h_ch7.tab3_1_1_1_5 hd_h_ch7.tab3_1_1_2_1 hd_h_ch7.tab3_1_1_2_2" colspan="2" rowspan="1" style="text-align:left;vertical-align:top;">Moderate</td></tr><tr><td headers="hd_h_ch7.tab3_1_1_1_5 hd_h_ch7.tab3_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">667 per 1,000</td><td headers="hd_h_ch7.tab3_1_1_1_5 hd_h_ch7.tab3_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>107 fewer per 1,000</p>
|
|
<p>(394 fewer to 480 more)</p>
|
|
</td></tr><tr><td headers="hd_h_ch7.tab3_1_1_1_1" rowspan="2" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Adverse events at ≥6 months</p>
|
|
<p>follow up: range 28 weeks to 52 weeks<sup>e</sup></p>
|
|
</td><td headers="hd_h_ch7.tab3_1_1_1_2" rowspan="2" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>145</p>
|
|
<p>(2 RCTs)</p>
|
|
</td><td headers="hd_h_ch7.tab3_1_1_1_3" rowspan="2" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>VERY LOW<sup>a</sup><sup>,</sup><sup>b</sup></p>
|
|
</td><td headers="hd_h_ch7.tab3_1_1_1_4" rowspan="2" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 1.36</p>
|
|
<p>(0.98 to 1.90)</p>
|
|
</td><td headers="hd_h_ch7.tab3_1_1_1_5 hd_h_ch7.tab3_1_1_2_1 hd_h_ch7.tab3_1_1_2_2" colspan="2" rowspan="1" style="text-align:left;vertical-align:top;">Moderate</td></tr><tr><td headers="hd_h_ch7.tab3_1_1_1_5 hd_h_ch7.tab3_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">373 per 1,000</td><td headers="hd_h_ch7.tab3_1_1_1_5 hd_h_ch7.tab3_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>134 more per 1,000</p>
|
|
<p>(7 fewer to 336 more)</p>
|
|
</td></tr><tr><td headers="hd_h_ch7.tab3_1_1_1_1" rowspan="2" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Serious adverse events at ≥6 months</p>
|
|
<p>follow up: 28 weeks</p>
|
|
</td><td headers="hd_h_ch7.tab3_1_1_1_2" rowspan="2" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>67</p>
|
|
<p>(1 RCT)</p>
|
|
</td><td headers="hd_h_ch7.tab3_1_1_1_3" rowspan="2" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>VERY LOW<sup>a</sup><sup>,</sup><sup>b</sup></p>
|
|
</td><td headers="hd_h_ch7.tab3_1_1_1_4" rowspan="2" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 0.77</p>
|
|
<p>(0.19 to 3.19)</p>
|
|
</td><td headers="hd_h_ch7.tab3_1_1_1_5 hd_h_ch7.tab3_1_1_2_1 hd_h_ch7.tab3_1_1_2_2" colspan="2" rowspan="1" style="text-align:left;vertical-align:top;">Moderate</td></tr><tr><td headers="hd_h_ch7.tab3_1_1_1_5 hd_h_ch7.tab3_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">118 per 1,000</td><td headers="hd_h_ch7.tab3_1_1_1_5 hd_h_ch7.tab3_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>27 fewer per 1,000</p>
|
|
<p>(95 fewer to 258 more)</p>
|
|
</td></tr></tbody></table></div><div class="tblwrap-foot"><div><dl class="temp-labeled-list small"><dl class="bkr_refwrap"><dt>a</dt><dd><div id="ch7.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 a very high risk of bias</p></div></dd></dl><dl class="bkr_refwrap"><dt>b</dt><dd><div id="ch7.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></dl><dl class="bkr_refwrap"><dt>c</dt><dd><div id="ch7.tab3_3"><p class="no_margin">Established MIDs used for SF36</p></div></dd></dl><dl class="bkr_refwrap"><dt>d</dt><dd><div id="ch7.tab3_4"><p class="no_margin">Fatal event in the study was considered as unrelated to the intervention. One patient died due to decreased appetite (anorexia). The patient had a history of dementia and was taking concurrent medications including haloperidol.</p></div></dd></dl><dl class="bkr_refwrap"><dt>e</dt><dd><div id="ch7.tab3_5"><p class="no_margin">Actual outcome reported in one study was the number of people withdrawing due to adverse events (not the total number of people having adverse events). The other study reported the total number of people having adverse events, with the most frequent events being nausea and muscle spasms.</p></div></dd></dl></dl></div></div></div></article><article data-type="table-wrap" id="figobch7tab4"><div id="ch7.tab4" class="table"><h3><span class="label">Table 4</span><span class="title">Cost of cinacalcet</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK577894/table/ch7.tab4/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__ch7.tab4_lrgtbl__"><table class="no_bottom_margin"><thead><tr><th id="hd_h_ch7.tab4_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:middle;">Drug</th><th id="hd_h_ch7.tab4_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:middle;">Daily dose (or unit or total)</th><th id="hd_h_ch7.tab4_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:middle;">Cost – per month</th><th id="hd_h_ch7.tab4_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:middle;">Cost – annual (or per course)</th></tr></thead><tbody><tr><td headers="hd_h_ch7.tab4_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Cinacalcet</td><td headers="hd_h_ch7.tab4_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">60 mg (30 mg twice daily)</td><td headers="hd_h_ch7.tab4_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">£273</td><td headers="hd_h_ch7.tab4_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">£3,278</td></tr></tbody></table></div><div class="tblwrap-foot"><div><dl class="temp-labeled-list small"><dl class="bkr_refwrap"><dt></dt><dd><div><p class="no_margin">Source: BNF – September 2017<a class="bibr" href="#ch7.ref9" rid="ch7.ref9"><sup>9</sup></a></p></div></dd></dl></dl></div></div></div></article><article data-type="table-wrap" id="figobch7appatab1"><div id="ch7.appa.tab1" class="table"><h3><span class="label">Table 5</span><span class="title">Review protocol: Calcimimetics</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK577894/table/ch7.appa.tab1/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__ch7.appa.tab1_lrgtbl__"><table><thead><tr><th id="hd_h_ch7.appa.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Field</th><th id="hd_h_ch7.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_ch7.appa.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Review question</td><td headers="hd_h_ch7.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 calcimimetics in people with primary hyperparathyroidism?</td></tr><tr><td headers="hd_h_ch7.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_ch7.appa.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Intervention</td></tr><tr><td headers="hd_h_ch7.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_ch7.appa.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">To assess the effectiveness of calcimimetics in people with primary hyperparathyroidism</td></tr><tr><td headers="hd_h_ch7.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_ch7.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:
|
|
<ul id="ch7.l8"><li id="ch7.lt21" 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="ch7.lt22" class="half_rhythm"><div>Previous parathyroidectomy</div></li><li id="ch7.lt23" class="half_rhythm"><div>Pregnant women</div></li></ul>
|
|
Exclude people:
|
|
<ul id="ch7.l9"><li id="ch7.lt24" class="half_rhythm"><div>with secondary and tertiary HPT</div></li><li id="ch7.lt25" class="half_rhythm"><div>with multiple endocrine neoplasia (MEN)</div></li><li id="ch7.lt26" class="half_rhythm"><div>with familial hyperparathyroidism</div></li><li id="ch7.lt27" class="half_rhythm"><div>with parathyroid carcinoma</div></li><li id="ch7.lt28" class="half_rhythm"><div>people 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 are reported separately by type of hyperparathyroidism.</p>
|
|
</td></tr><tr><td headers="hd_h_ch7.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_ch7.appa.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Oral calcimimetics (cinacalcet)</td></tr><tr><td headers="hd_h_ch7.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_ch7.appa.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<ul id="ch7.l10"><li id="ch7.lt29" class="half_rhythm"><div>Placebo</div></li><li id="ch7.lt30" class="half_rhythm"><div>No treatment (surveillance/conservative management)</div></li><li id="ch7.lt31" class="half_rhythm"><div>Surgery (see protocol in <a href="/books/n/niceng132er3/?report=reader" class="toc-item">evidence report C</a>)</div></li><li id="ch7.lt32" class="half_rhythm"><div>Bisphosphonates</div></li><li id="ch7.lt33" 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_ch7.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_ch7.appa.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>
|
|
<b>Report all outcomes separately for <6 months and ≥6 months</b>
|
|
</p>
|
|
<p><b>Critical outcomes:</b>
|
|
<ul id="ch7.l11"><li id="ch7.lt34" class="half_rhythm"><div>HRQOL (continuous outcome)</div></li><li id="ch7.lt35" class="half_rhythm"><div>Mortality (dichotomous outcome)</div></li></ul>
|
|
<b>Important outcomes:</b>
|
|
<ul id="ch7.l12"><li id="ch7.lt36" class="half_rhythm"><div>Deterioration in renal function (dichotomous - study may also report renal replacement)</div></li><li id="ch7.lt37" class="half_rhythm"><div>Fractures (vertebral or long bone) (dichotomous outcome)</div></li><li id="ch7.lt38" class="half_rhythm"><div>Occurrence of kidney stones (dichotomous outcome)</div></li><li id="ch7.lt39" class="half_rhythm"><div>Persistent hypercalcaemia (dichotomous outcome)</div></li><li id="ch7.lt40" class="half_rhythm"><div>BMD (continuous) of the distal radius or the lumbar spine</div></li><li id="ch7.lt41" class="half_rhythm"><div>Cardiovascular events (dichotomous outcome)</div></li><li id="ch7.lt42" class="half_rhythm"><div>Adverse events (to include discontinuation due to side effects; dichotomous outcome)</div></li><li id="ch7.lt43" class="half_rhythm"><div>Cancer incidence (dichotomous outcome)</div></li></ul></p>
|
|
</td></tr><tr><td headers="hd_h_ch7.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_ch7.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) Key confounders:
|
|
<ul id="ch7.l13"><li id="ch7.lt44" class="half_rhythm"><div>Age</div></li><li id="ch7.lt45" class="half_rhythm"><div>Absence/presence of end-organ effects</div></li><li id="ch7.lt46" class="half_rhythm"><div>Adjusted serum calcium level</div></li></ul></p>
|
|
</td></tr><tr><td headers="hd_h_ch7.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_ch7.appa.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<ul id="ch7.l14"><li id="ch7.lt47" class="half_rhythm"><div>Non-English language articles</div></li><li id="ch7.lt48" class="half_rhythm"><div>Conference abstracts</div></li></ul></td></tr><tr><td headers="hd_h_ch7.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_ch7.appa.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Subgroups will be investigated in the following order if there is heterogeneity in the data:
|
|
<ul id="ch7.l15"><li id="ch7.lt49" class="half_rhythm"><div>Adjusted serum calcium ≥2.85 mmol/L and <2.85 mmol/L)</div></li><li id="ch7.lt50" class="half_rhythm"><div>People with end-organ effects versus absence of end-organ effects (end organ effects defined as kidney stones, history of fragility fractures or osteoporosis [BMD T-score <-2.5 at any site])</div></li></ul></td></tr><tr><td headers="hd_h_ch7.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_ch7.appa.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<ul id="ch7.l16"><li id="ch7.lt51" class="half_rhythm"><div>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.</div></li></ul></td></tr><tr><td headers="hd_h_ch7.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_ch7.appa.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<ul id="ch7.l17"><li id="ch7.lt52" class="half_rhythm"><div>Pairwise meta-analyses were performed using Cochrane Review Manager (RevMan5).</div></li><li id="ch7.lt53" class="half_rhythm"><div>GRADEpro was used to assess the quality of evidence for each outcome.</div></li><li id="ch7.lt54" class="half_rhythm"><div>Endnote for bibliography, citations, sifting and reference management</div></li><li id="ch7.lt55" class="half_rhythm"><div>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_ch7.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_ch7.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_ch7.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_ch7.appa.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">N/A</td></tr><tr><td headers="hd_h_ch7.appa.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Author contacts</td><td headers="hd_h_ch7.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>
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</td></tr><tr><td headers="hd_h_ch7.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_ch7.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_ch7.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_ch7.appa.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">For details please see <a href="#ch7.appb">appendix B</a></td></tr><tr><td headers="hd_h_ch7.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_ch7.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="#ch7.appd">appendix D</a> of the evidence report.</td></tr><tr><td headers="hd_h_ch7.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_ch7.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="#ch7.appd">Appendix D</a> (clinical evidence tables) or <a href="#ch7.apph">H</a> (health economic evidence tables).</td></tr><tr><td headers="hd_h_ch7.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_ch7.appa.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>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></p>
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<p>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></p>
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</td></tr><tr><td headers="hd_h_ch7.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_ch7.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_ch7.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_ch7.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_ch7.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_ch7.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_ch7.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_ch7.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_ch7.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_ch7.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_ch7.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_ch7.appa.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<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>
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<p>Staff from 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>
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</td></tr><tr><td headers="hd_h_ch7.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_ch7.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_ch7.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_ch7.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_ch7.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_ch7.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_ch7.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_ch7.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></article><article data-type="table-wrap" id="figobch7appatab2"><div id="ch7.appa.tab2" class="table"><h3><span class="label">Table 6</span><span class="title">Health economic review protocol</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK577894/table/ch7.appa.tab2/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__ch7.appa.tab2_lrgtbl__"><table><thead><tr><th id="hd_h_ch7.appa.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:middle;">Review question</th><th id="hd_h_ch7.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_ch7.appa.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<b>Objectives</b>
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</td><td headers="hd_h_ch7.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_ch7.appa.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<b>Search criteria</b>
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</td><td headers="hd_h_ch7.appa.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<ul id="ch7.l18"><li id="ch7.lt56" class="half_rhythm"><div>Populations, interventions and comparators must be as specified in the clinical review protocol above.</div></li><li id="ch7.lt57" class="half_rhythm"><div>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="ch7.lt58" class="half_rhythm"><div>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="ch7.lt59" class="half_rhythm"><div>Unpublished reports will not be considered unless submitted as part of a call for evidence.</div></li></ul>
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Studies must be in English.</td></tr><tr><td headers="hd_h_ch7.appa.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<b>Search strategy</b>
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</td><td headers="hd_h_ch7.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="#ch7.appb">appendix B</a> below.</td></tr><tr><td headers="hd_h_ch7.appa.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<b>Review strategy</b>
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</td><td headers="hd_h_ch7.appa.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<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>
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<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="#ch7.apph">appendix H</a> of Developing NICE guidelines: the manual (2014).<a class="bibr" href="#ch7.ref16" rid="ch7.ref16"><sup>16</sup></a></p>
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<p><b>Inclusion and exclusion criteria</b>
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<ul id="ch7.l19"><li id="ch7.lt60" 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="ch7.lt61" 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="ch7.lt62" 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>
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<b>Where there is discretion</b></p>
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<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>
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<p>The health economist will be guided by the following hierarchies.</p>
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<p><i>Setting:</i>
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<ul id="ch7.l20"><li id="ch7.lt63" class="half_rhythm"><div>UK NHS (most applicable).</div></li><li id="ch7.lt64" class="half_rhythm"><div>OECD countries with predominantly public health insurance systems (for example, France, Germany, Sweden).</div></li><li id="ch7.lt65" class="half_rhythm"><div>OECD countries with predominantly private health insurance systems (for example, Switzerland).</div></li><li id="ch7.lt66" 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>
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<i>Health economic study type:</i>
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<ul id="ch7.l21"><li id="ch7.lt67" class="half_rhythm"><div>Cost–utility analysis (most applicable).</div></li><li id="ch7.lt68" class="half_rhythm"><div>Other type of full economic evaluation (cost–benefit analysis, cost-effectiveness analysis, cost–consequences analysis).</div></li><li id="ch7.lt69" class="half_rhythm"><div>Comparative cost analysis.</div></li><li id="ch7.lt70" 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>
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<i>Year of analysis:</i>
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<ul id="ch7.l22"><li id="ch7.lt71" class="half_rhythm"><div>The more recent the study, the more applicable it will be.</div></li><li id="ch7.lt72" 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="ch7.lt73" class="half_rhythm"><div>Studies published before 2002 will be excluded before being assessed for applicability and methodological limitations.</div></li></ul>
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<i>Quality and relevance of effectiveness data used in the health economic analysis:</i>
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<ul id="ch7.l23"><li id="ch7.lt74" 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>
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</td></tr></tbody></table></div></div></article><article data-type="table-wrap" id="figobch7appbtab1"><div id="ch7.appb.tab1" class="table"><h3><span class="label">Table 7</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/NBK577894/table/ch7.appb.tab1/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__ch7.appb.tab1_lrgtbl__"><table><thead><tr><th id="hd_h_ch7.appb.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Database</th><th id="hd_h_ch7.appb.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Dates searched</th><th id="hd_h_ch7.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_ch7.appb.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Medline (OVID)</td><td headers="hd_h_ch7.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_ch7.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_ch7.appb.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Embase (OVID)</td><td headers="hd_h_ch7.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_ch7.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_ch7.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_ch7.appb.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>Cochrane Reviews to 2018</p>
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<p>Issue 8 of 12</p>
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<p>CENTRAL to 2018 Issue 7 of 12</p>
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<p>DARE, and NHSEED to 2015</p>
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<p>Issue 2 of 4</p>
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<p>HTA to 2016 Issue 4 of 4</p>
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</td><td headers="hd_h_ch7.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_ch7.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_ch7.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_ch7.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_ch7.appb.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">PsycINFO (ProQuest)</td><td headers="hd_h_ch7.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_ch7.appb.tab1_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Exclusions</td></tr></tbody></table></div></div></article><article data-type="table-wrap" id="figobch7appbtab2"><div id="ch7.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/NBK577894/table/ch7.appb.tab2/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__ch7.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></article><article data-type="table-wrap" id="figobch7appbtab3"><div id="ch7.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/NBK577894/table/ch7.appb.tab3/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__ch7.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></article><article data-type="table-wrap" id="figobch7appbtab4"><div id="ch7.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/NBK577894/table/ch7.appb.tab4/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__ch7.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></article><article data-type="table-wrap" id="figobch7appbtab5"><div id="ch7.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/NBK577894/table/ch7.appb.tab5/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__ch7.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></article><article data-type="table-wrap" id="figobch7appbtab6"><div id="ch7.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/NBK577894/table/ch7.appb.tab6/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__ch7.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></article><article data-type="table-wrap" id="figobch7appbtab7"><div id="ch7.appb.tab7" 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/NBK577894/table/ch7.appb.tab7/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__ch7.appb.tab7_lrgtbl__"><table><thead><tr><th id="hd_h_ch7.appb.tab7_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Database</th><th id="hd_h_ch7.appb.tab7_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Dates searched</th><th id="hd_h_ch7.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_ch7.appb.tab7_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Medline</td><td headers="hd_h_ch7.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_ch7.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_ch7.appb.tab7_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Embase</td><td headers="hd_h_ch7.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_ch7.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_ch7.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_ch7.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_ch7.appb.tab7_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">None</td></tr></tbody></table></div></div></article><article data-type="table-wrap" id="figobch7appbtab8"><div id="ch7.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/NBK577894/table/ch7.appb.tab8/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__ch7.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></article><article data-type="table-wrap" id="figobch7appbtab9"><div id="ch7.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/NBK577894/table/ch7.appb.tab9/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__ch7.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></article><article data-type="table-wrap" id="figobch7appbtab10"><div id="ch7.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/NBK577894/table/ch7.appb.tab10/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__ch7.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></article><article data-type="fig" id="figobch7appcfig1"><div id="ch7.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=577894_ch7appcf1.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 data-src="/books/NBK577894/bin/ch7appcf1.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></article><article data-type="fig" id="figobch7appefig1"><div id="ch7.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.%20SF-36%20physical%20component.&p=BOOKS&id=577894_ch7appef1.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 data-src="/books/NBK577894/bin/ch7appef1.jpg" alt="Figure 2. SF-36 physical component." class="tileshop" title="Click on image to zoom" /></a></div><h3><span class="label">Figure 2</span><span class="title">SF-36 physical component</span></h3></div></article><article data-type="fig" id="figobch7appefig2"><div id="ch7.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.%20SF-36%20mental%20component.&p=BOOKS&id=577894_ch7appef2.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 data-src="/books/NBK577894/bin/ch7appef2.jpg" alt="Figure 3. SF-36 mental component." class="tileshop" title="Click on image to zoom" /></a></div><h3><span class="label">Figure 3</span><span class="title">SF-36 mental component</span></h3></div></article><article data-type="fig" id="figobch7appefig3"><div id="ch7.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.%20MOS-CF%20scores.&p=BOOKS&id=577894_ch7appef3.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 data-src="/books/NBK577894/bin/ch7appef3.jpg" alt="Figure 4. MOS-CF scores." class="tileshop" title="Click on image to zoom" /></a></div><h3><span class="label">Figure 4</span><span class="title">MOS-CF scores</span></h3></div></article><article data-type="fig" id="figobch7appefig4"><div id="ch7.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.%20PAS%20scores.&p=BOOKS&id=577894_ch7appef4.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 data-src="/books/NBK577894/bin/ch7appef4.jpg" alt="Figure 5. PAS scores." class="tileshop" title="Click on image to zoom" /></a></div><h3><span class="label">Figure 5</span><span class="title">PAS scores</span></h3></div></article><article data-type="fig" id="figobch7appefig5"><div id="ch7.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.%20Mortality.&p=BOOKS&id=577894_ch7appef5.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 data-src="/books/NBK577894/bin/ch7appef5.jpg" alt="Figure 6. Mortality." class="tileshop" title="Click on image to zoom" /></a></div><h3><span class="label">Figure 6</span><span class="title">Mortality</span></h3><div class="caption"><p>Fatal event in the study was considered as unrelated to the intervention. One patient died due to decreased appetite (anorexia). The patient had a history of dementia and was taking concurrent medications including haloperidol</p></div></div></article><article data-type="fig" id="figobch7appefig6"><div id="ch7.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.%20Achieving%20normocalcaemia.&p=BOOKS&id=577894_ch7appef6.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 data-src="/books/NBK577894/bin/ch7appef6.jpg" alt="Figure 7. Achieving normocalcaemia." class="tileshop" title="Click on image to zoom" /></a></div><h3><span class="label">Figure 7</span><span class="title">Achieving normocalcaemia</span></h3></div></article><article data-type="fig" id="figobch7appefig7"><div id="ch7.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.%20Lumbar%20spine%20BMD%20Z-score.&p=BOOKS&id=577894_ch7appef7.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 data-src="/books/NBK577894/bin/ch7appef7.jpg" alt="Figure 8. Lumbar spine BMD Z-score." class="tileshop" title="Click on image to zoom" /></a></div><h3><span class="label">Figure 8</span><span class="title">Lumbar spine BMD Z-score</span></h3></div></article><article data-type="fig" id="figobch7appefig8"><div id="ch7.appe.fig8" class="figure bk_fig"><div class="graphic"><a href="/core/lw/2.0/html/tileshop_pmc/tileshop_pmc_inline.html?title=Figure%209.%20Distal%20radius%20BMD%20Z-score.&p=BOOKS&id=577894_ch7appef8.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 data-src="/books/NBK577894/bin/ch7appef8.jpg" alt="Figure 9. Distal radius BMD Z-score." class="tileshop" title="Click on image to zoom" /></a></div><h3><span class="label">Figure 9</span><span class="title">Distal radius BMD Z-score</span></h3></div></article><article data-type="fig" id="figobch7appefig9"><div id="ch7.appe.fig9" class="figure bk_fig"><div class="graphic"><a href="/core/lw/2.0/html/tileshop_pmc/tileshop_pmc_inline.html?title=Figure%2010.%20Adverse%20events%20at%20%3C6%20months.&p=BOOKS&id=577894_ch7appef9.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 data-src="/books/NBK577894/bin/ch7appef9.jpg" alt="Figure 10. Adverse events at <6 months." class="tileshop" title="Click on image to zoom" /></a></div><h3><span class="label">Figure 10</span><span class="title">Adverse events at <6 months</span></h3></div></article><article data-type="fig" id="figobch7appefig10"><div id="ch7.appe.fig10" class="figure bk_fig"><div class="graphic"><a href="/core/lw/2.0/html/tileshop_pmc/tileshop_pmc_inline.html?title=Figure%2011.%20Adverse%20events%20at%20%022656%20months.&p=BOOKS&id=577894_ch7appef10.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 data-src="/books/NBK577894/bin/ch7appef10.jpg" alt="Figure 11. Adverse events at ≥6 months." class="tileshop" title="Click on image to zoom" /></a></div><h3><span class="label">Figure 11</span><span class="title">Adverse events at ≥6 months</span></h3><div class="caption"><p>Actual outcome reported in one study was the number of people withdrawing due to adverse events (not the total number of people having adverse events). The other study reported the total number of people having adverse events, with the most frequent events being nausea and muscle spasms</p></div></div></article><article data-type="fig" id="figobch7appefig11"><div id="ch7.appe.fig11" class="figure bk_fig"><div class="graphic"><a href="/core/lw/2.0/html/tileshop_pmc/tileshop_pmc_inline.html?title=Figure%2012.%20Serious%20adverse%20events.&p=BOOKS&id=577894_ch7appef11.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 data-src="/books/NBK577894/bin/ch7appef11.jpg" alt="Figure 12. Serious adverse events." class="tileshop" title="Click on image to zoom" /></a></div><h3><span class="label">Figure 12</span><span class="title">Serious adverse events</span></h3></div></article><article data-type="table-wrap" id="figobch7appftab1"><div id="ch7.appf.tab1" class="table"><h3><span class="label">Table 9</span><span class="title">Clinical evidence profile: Cinacalcet versus placebo</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK577894/table/ch7.appf.tab1/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__ch7.appf.tab1_lrgtbl__"><table class="no_bottom_margin"><thead><tr><th id="hd_h_ch7.appf.tab1_1_1_1_1" colspan="7" rowspan="1" style="text-align:center;vertical-align:middle;">Quality assessment</th><th id="hd_h_ch7.appf.tab1_1_1_1_2" colspan="2" rowspan="1" style="text-align:center;vertical-align:middle;">№ of patients</th><th id="hd_h_ch7.appf.tab1_1_1_1_3" colspan="2" rowspan="1" style="text-align:center;vertical-align:middle;">Effect</th><th id="hd_h_ch7.appf.tab1_1_1_1_4" rowspan="2" colspan="1" headers="hd_h_ch7.appf.tab1_1_1_1_4" style="text-align:center;vertical-align:middle;">Quality</th><th id="hd_h_ch7.appf.tab1_1_1_1_5" rowspan="2" colspan="1" headers="hd_h_ch7.appf.tab1_1_1_1_5" style="text-align:center;vertical-align:middle;">Importance</th></tr><tr><th headers="hd_h_ch7.appf.tab1_1_1_1_1" id="hd_h_ch7.appf.tab1_1_1_2_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">№ of studies</th><th headers="hd_h_ch7.appf.tab1_1_1_1_1" id="hd_h_ch7.appf.tab1_1_1_2_2" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">Study design</th><th headers="hd_h_ch7.appf.tab1_1_1_1_1" id="hd_h_ch7.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_ch7.appf.tab1_1_1_1_1" id="hd_h_ch7.appf.tab1_1_1_2_4" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">Inconsistency</th><th headers="hd_h_ch7.appf.tab1_1_1_1_1" id="hd_h_ch7.appf.tab1_1_1_2_5" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">Indirectness</th><th headers="hd_h_ch7.appf.tab1_1_1_1_1" id="hd_h_ch7.appf.tab1_1_1_2_6" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">Imprecision</th><th headers="hd_h_ch7.appf.tab1_1_1_1_1" id="hd_h_ch7.appf.tab1_1_1_2_7" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">Other considerations</th><th headers="hd_h_ch7.appf.tab1_1_1_1_2" id="hd_h_ch7.appf.tab1_1_1_2_8" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">Cinacalcet</th><th headers="hd_h_ch7.appf.tab1_1_1_1_2" id="hd_h_ch7.appf.tab1_1_1_2_9" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">Placebo</th><th headers="hd_h_ch7.appf.tab1_1_1_1_3" id="hd_h_ch7.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_ch7.appf.tab1_1_1_1_3" id="hd_h_ch7.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_ch7.appf.tab1_1_1_1_1 hd_h_ch7.appf.tab1_1_1_2_1 hd_h_ch7.appf.tab1_1_1_2_2 hd_h_ch7.appf.tab1_1_1_2_3 hd_h_ch7.appf.tab1_1_1_2_4 hd_h_ch7.appf.tab1_1_1_2_5 hd_h_ch7.appf.tab1_1_1_2_6 hd_h_ch7.appf.tab1_1_1_2_7 hd_h_ch7.appf.tab1_1_1_1_2 hd_h_ch7.appf.tab1_1_1_2_8 hd_h_ch7.appf.tab1_1_1_2_9 hd_h_ch7.appf.tab1_1_1_1_3 hd_h_ch7.appf.tab1_1_1_2_10 hd_h_ch7.appf.tab1_1_1_2_11 hd_h_ch7.appf.tab1_1_1_1_4 hd_h_ch7.appf.tab1_1_1_1_5" id="hd_b_ch7.appf.tab1_1_1_1_1" colspan="13" rowspan="1" style="text-align:left;vertical-align:middle;">SF-36 physical component (follow up: 28 weeks; Scale from: 0 to 100 higher scores indicate better outcomes; change score)</th></tr><tr><td headers="hd_h_ch7.appf.tab1_1_1_1_1 hd_h_ch7.appf.tab1_1_1_2_1 hd_b_ch7.appf.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">1</td><td headers="hd_h_ch7.appf.tab1_1_1_1_1 hd_h_ch7.appf.tab1_1_1_2_2 hd_b_ch7.appf.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">randomised trials</td><td headers="hd_h_ch7.appf.tab1_1_1_1_1 hd_h_ch7.appf.tab1_1_1_2_3 hd_b_ch7.appf.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">very serious<sup>a</sup></td><td headers="hd_h_ch7.appf.tab1_1_1_1_1 hd_h_ch7.appf.tab1_1_1_2_4 hd_b_ch7.appf.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">not serious</td><td headers="hd_h_ch7.appf.tab1_1_1_1_1 hd_h_ch7.appf.tab1_1_1_2_5 hd_b_ch7.appf.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">not serious</td><td headers="hd_h_ch7.appf.tab1_1_1_1_1 hd_h_ch7.appf.tab1_1_1_2_6 hd_b_ch7.appf.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">serious<sup>b</sup><sup>,</sup><sup>c</sup></td><td headers="hd_h_ch7.appf.tab1_1_1_1_1 hd_h_ch7.appf.tab1_1_1_2_7 hd_b_ch7.appf.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">none</td><td headers="hd_h_ch7.appf.tab1_1_1_1_2 hd_h_ch7.appf.tab1_1_1_2_8 hd_b_ch7.appf.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:top;">33</td><td headers="hd_h_ch7.appf.tab1_1_1_1_2 hd_h_ch7.appf.tab1_1_1_2_9 hd_b_ch7.appf.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:top;">34</td><td headers="hd_h_ch7.appf.tab1_1_1_1_3 hd_h_ch7.appf.tab1_1_1_2_10 hd_b_ch7.appf.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:top;">-</td><td headers="hd_h_ch7.appf.tab1_1_1_1_3 hd_h_ch7.appf.tab1_1_1_2_11 hd_b_ch7.appf.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:top;">MD <b>2.9 higher</b> (0.29 lower to 6.09 higher)</td><td headers="hd_h_ch7.appf.tab1_1_1_1_4 hd_b_ch7.appf.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:top;">
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<p>⨁◯◯◯</p>
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<p>VERY LOW</p>
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</td><td headers="hd_h_ch7.appf.tab1_1_1_1_5 hd_b_ch7.appf.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">CRITICAL</td></tr><tr><th headers="hd_h_ch7.appf.tab1_1_1_1_1 hd_h_ch7.appf.tab1_1_1_2_1 hd_h_ch7.appf.tab1_1_1_2_2 hd_h_ch7.appf.tab1_1_1_2_3 hd_h_ch7.appf.tab1_1_1_2_4 hd_h_ch7.appf.tab1_1_1_2_5 hd_h_ch7.appf.tab1_1_1_2_6 hd_h_ch7.appf.tab1_1_1_2_7 hd_h_ch7.appf.tab1_1_1_1_2 hd_h_ch7.appf.tab1_1_1_2_8 hd_h_ch7.appf.tab1_1_1_2_9 hd_h_ch7.appf.tab1_1_1_1_3 hd_h_ch7.appf.tab1_1_1_2_10 hd_h_ch7.appf.tab1_1_1_2_11 hd_h_ch7.appf.tab1_1_1_1_4 hd_h_ch7.appf.tab1_1_1_1_5" id="hd_b_ch7.appf.tab1_1_1_3_1" colspan="13" rowspan="1" style="text-align:left;vertical-align:middle;">SF-36 mental component (follow up: 28 weeks; Scale from: 0 to 100 higher scores indicate better outcomes; change score)</th></tr><tr><td headers="hd_h_ch7.appf.tab1_1_1_1_1 hd_h_ch7.appf.tab1_1_1_2_1 hd_b_ch7.appf.tab1_1_1_3_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">1</td><td headers="hd_h_ch7.appf.tab1_1_1_1_1 hd_h_ch7.appf.tab1_1_1_2_2 hd_b_ch7.appf.tab1_1_1_3_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">randomised trials</td><td headers="hd_h_ch7.appf.tab1_1_1_1_1 hd_h_ch7.appf.tab1_1_1_2_3 hd_b_ch7.appf.tab1_1_1_3_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">very serious<sup>a</sup></td><td headers="hd_h_ch7.appf.tab1_1_1_1_1 hd_h_ch7.appf.tab1_1_1_2_4 hd_b_ch7.appf.tab1_1_1_3_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">not serious</td><td headers="hd_h_ch7.appf.tab1_1_1_1_1 hd_h_ch7.appf.tab1_1_1_2_5 hd_b_ch7.appf.tab1_1_1_3_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">not serious</td><td headers="hd_h_ch7.appf.tab1_1_1_1_1 hd_h_ch7.appf.tab1_1_1_2_6 hd_b_ch7.appf.tab1_1_1_3_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">serious<sup>b</sup><sup>,</sup><sup>c</sup></td><td headers="hd_h_ch7.appf.tab1_1_1_1_1 hd_h_ch7.appf.tab1_1_1_2_7 hd_b_ch7.appf.tab1_1_1_3_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">none</td><td headers="hd_h_ch7.appf.tab1_1_1_1_2 hd_h_ch7.appf.tab1_1_1_2_8 hd_b_ch7.appf.tab1_1_1_3_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:top;">33</td><td headers="hd_h_ch7.appf.tab1_1_1_1_2 hd_h_ch7.appf.tab1_1_1_2_9 hd_b_ch7.appf.tab1_1_1_3_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:top;">34</td><td headers="hd_h_ch7.appf.tab1_1_1_1_3 hd_h_ch7.appf.tab1_1_1_2_10 hd_b_ch7.appf.tab1_1_1_3_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:top;">-</td><td headers="hd_h_ch7.appf.tab1_1_1_1_3 hd_h_ch7.appf.tab1_1_1_2_11 hd_b_ch7.appf.tab1_1_1_3_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:top;">MD <b>4.3 higher</b> (0 to 8.6 higher)</td><td headers="hd_h_ch7.appf.tab1_1_1_1_4 hd_b_ch7.appf.tab1_1_1_3_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:top;">
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<p>⨁◯◯◯</p>
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<p>VERY LOW</p>
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</td><td headers="hd_h_ch7.appf.tab1_1_1_1_5 hd_b_ch7.appf.tab1_1_1_3_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">CRITICAL</td></tr><tr><th headers="hd_h_ch7.appf.tab1_1_1_1_1 hd_h_ch7.appf.tab1_1_1_2_1 hd_h_ch7.appf.tab1_1_1_2_2 hd_h_ch7.appf.tab1_1_1_2_3 hd_h_ch7.appf.tab1_1_1_2_4 hd_h_ch7.appf.tab1_1_1_2_5 hd_h_ch7.appf.tab1_1_1_2_6 hd_h_ch7.appf.tab1_1_1_2_7 hd_h_ch7.appf.tab1_1_1_1_2 hd_h_ch7.appf.tab1_1_1_2_8 hd_h_ch7.appf.tab1_1_1_2_9 hd_h_ch7.appf.tab1_1_1_1_3 hd_h_ch7.appf.tab1_1_1_2_10 hd_h_ch7.appf.tab1_1_1_2_11 hd_h_ch7.appf.tab1_1_1_1_4 hd_h_ch7.appf.tab1_1_1_1_5" id="hd_b_ch7.appf.tab1_1_1_5_1" colspan="13" rowspan="1" style="text-align:left;vertical-align:middle;">MOS-CF (follow up: 28 weeks; Scale from: 0 to 100 higher scores indicate better outcomes; change score)</th></tr><tr><td headers="hd_h_ch7.appf.tab1_1_1_1_1 hd_h_ch7.appf.tab1_1_1_2_1 hd_b_ch7.appf.tab1_1_1_5_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">1</td><td headers="hd_h_ch7.appf.tab1_1_1_1_1 hd_h_ch7.appf.tab1_1_1_2_2 hd_b_ch7.appf.tab1_1_1_5_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">randomised trials</td><td headers="hd_h_ch7.appf.tab1_1_1_1_1 hd_h_ch7.appf.tab1_1_1_2_3 hd_b_ch7.appf.tab1_1_1_5_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">very serious<sup>a</sup></td><td headers="hd_h_ch7.appf.tab1_1_1_1_1 hd_h_ch7.appf.tab1_1_1_2_4 hd_b_ch7.appf.tab1_1_1_5_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">not serious</td><td headers="hd_h_ch7.appf.tab1_1_1_1_1 hd_h_ch7.appf.tab1_1_1_2_5 hd_b_ch7.appf.tab1_1_1_5_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">not serious</td><td headers="hd_h_ch7.appf.tab1_1_1_1_1 hd_h_ch7.appf.tab1_1_1_2_6 hd_b_ch7.appf.tab1_1_1_5_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">serious<sup>b</sup></td><td headers="hd_h_ch7.appf.tab1_1_1_1_1 hd_h_ch7.appf.tab1_1_1_2_7 hd_b_ch7.appf.tab1_1_1_5_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">none</td><td headers="hd_h_ch7.appf.tab1_1_1_1_2 hd_h_ch7.appf.tab1_1_1_2_8 hd_b_ch7.appf.tab1_1_1_5_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:top;">33</td><td headers="hd_h_ch7.appf.tab1_1_1_1_2 hd_h_ch7.appf.tab1_1_1_2_9 hd_b_ch7.appf.tab1_1_1_5_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:top;">34</td><td headers="hd_h_ch7.appf.tab1_1_1_1_3 hd_h_ch7.appf.tab1_1_1_2_10 hd_b_ch7.appf.tab1_1_1_5_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:top;">-</td><td headers="hd_h_ch7.appf.tab1_1_1_1_3 hd_h_ch7.appf.tab1_1_1_2_11 hd_b_ch7.appf.tab1_1_1_5_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:top;">MD <b>8.7 higher</b> (0.59 lower to 17.99 higher)</td><td headers="hd_h_ch7.appf.tab1_1_1_1_4 hd_b_ch7.appf.tab1_1_1_5_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:top;">
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<p>⨁◯◯◯</p>
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<p>VERY LOW</p>
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</td><td headers="hd_h_ch7.appf.tab1_1_1_1_5 hd_b_ch7.appf.tab1_1_1_5_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">CRITICAL</td></tr><tr><th headers="hd_h_ch7.appf.tab1_1_1_1_1 hd_h_ch7.appf.tab1_1_1_2_1 hd_h_ch7.appf.tab1_1_1_2_2 hd_h_ch7.appf.tab1_1_1_2_3 hd_h_ch7.appf.tab1_1_1_2_4 hd_h_ch7.appf.tab1_1_1_2_5 hd_h_ch7.appf.tab1_1_1_2_6 hd_h_ch7.appf.tab1_1_1_2_7 hd_h_ch7.appf.tab1_1_1_1_2 hd_h_ch7.appf.tab1_1_1_2_8 hd_h_ch7.appf.tab1_1_1_2_9 hd_h_ch7.appf.tab1_1_1_1_3 hd_h_ch7.appf.tab1_1_1_2_10 hd_h_ch7.appf.tab1_1_1_2_11 hd_h_ch7.appf.tab1_1_1_1_4 hd_h_ch7.appf.tab1_1_1_1_5" id="hd_b_ch7.appf.tab1_1_1_7_1" colspan="13" rowspan="1" style="text-align:left;vertical-align:middle;">PAS (follow up: 28 weeks; Scale from: 0 to 1300 higher scores indicate poorer outcomes; change score)</th></tr><tr><td headers="hd_h_ch7.appf.tab1_1_1_1_1 hd_h_ch7.appf.tab1_1_1_2_1 hd_b_ch7.appf.tab1_1_1_7_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">1</td><td headers="hd_h_ch7.appf.tab1_1_1_1_1 hd_h_ch7.appf.tab1_1_1_2_2 hd_b_ch7.appf.tab1_1_1_7_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">randomised trials</td><td headers="hd_h_ch7.appf.tab1_1_1_1_1 hd_h_ch7.appf.tab1_1_1_2_3 hd_b_ch7.appf.tab1_1_1_7_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">very serious<sup>a</sup></td><td headers="hd_h_ch7.appf.tab1_1_1_1_1 hd_h_ch7.appf.tab1_1_1_2_4 hd_b_ch7.appf.tab1_1_1_7_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">not serious</td><td headers="hd_h_ch7.appf.tab1_1_1_1_1 hd_h_ch7.appf.tab1_1_1_2_5 hd_b_ch7.appf.tab1_1_1_7_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">not serious</td><td headers="hd_h_ch7.appf.tab1_1_1_1_1 hd_h_ch7.appf.tab1_1_1_2_6 hd_b_ch7.appf.tab1_1_1_7_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">serious<sup>b</sup></td><td headers="hd_h_ch7.appf.tab1_1_1_1_1 hd_h_ch7.appf.tab1_1_1_2_7 hd_b_ch7.appf.tab1_1_1_7_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">none</td><td headers="hd_h_ch7.appf.tab1_1_1_1_2 hd_h_ch7.appf.tab1_1_1_2_8 hd_b_ch7.appf.tab1_1_1_7_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:top;">33</td><td headers="hd_h_ch7.appf.tab1_1_1_1_2 hd_h_ch7.appf.tab1_1_1_2_9 hd_b_ch7.appf.tab1_1_1_7_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:top;">34</td><td headers="hd_h_ch7.appf.tab1_1_1_1_3 hd_h_ch7.appf.tab1_1_1_2_10 hd_b_ch7.appf.tab1_1_1_7_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:top;">-</td><td headers="hd_h_ch7.appf.tab1_1_1_1_3 hd_h_ch7.appf.tab1_1_1_2_11 hd_b_ch7.appf.tab1_1_1_7_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:top;">MD <b>32 lower</b> (132.23 lower to 68.23 higher)</td><td headers="hd_h_ch7.appf.tab1_1_1_1_4 hd_b_ch7.appf.tab1_1_1_7_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:top;">
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<p>⨁◯◯◯</p>
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<p>VERY LOW</p>
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</td><td headers="hd_h_ch7.appf.tab1_1_1_1_5 hd_b_ch7.appf.tab1_1_1_7_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">CRITICAL</td></tr><tr><th headers="hd_h_ch7.appf.tab1_1_1_1_1 hd_h_ch7.appf.tab1_1_1_2_1 hd_h_ch7.appf.tab1_1_1_2_2 hd_h_ch7.appf.tab1_1_1_2_3 hd_h_ch7.appf.tab1_1_1_2_4 hd_h_ch7.appf.tab1_1_1_2_5 hd_h_ch7.appf.tab1_1_1_2_6 hd_h_ch7.appf.tab1_1_1_2_7 hd_h_ch7.appf.tab1_1_1_1_2 hd_h_ch7.appf.tab1_1_1_2_8 hd_h_ch7.appf.tab1_1_1_2_9 hd_h_ch7.appf.tab1_1_1_1_3 hd_h_ch7.appf.tab1_1_1_2_10 hd_h_ch7.appf.tab1_1_1_2_11 hd_h_ch7.appf.tab1_1_1_1_4 hd_h_ch7.appf.tab1_1_1_1_5" id="hd_b_ch7.appf.tab1_1_1_9_1" colspan="13" rowspan="1" style="text-align:left;vertical-align:middle;">Mortality (follow up: 28 weeks)<sup>d</sup></th></tr><tr><td headers="hd_h_ch7.appf.tab1_1_1_1_1 hd_h_ch7.appf.tab1_1_1_2_1 hd_b_ch7.appf.tab1_1_1_9_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">1</td><td headers="hd_h_ch7.appf.tab1_1_1_1_1 hd_h_ch7.appf.tab1_1_1_2_2 hd_b_ch7.appf.tab1_1_1_9_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">randomised trials</td><td headers="hd_h_ch7.appf.tab1_1_1_1_1 hd_h_ch7.appf.tab1_1_1_2_3 hd_b_ch7.appf.tab1_1_1_9_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">very serious<sup>a</sup></td><td headers="hd_h_ch7.appf.tab1_1_1_1_1 hd_h_ch7.appf.tab1_1_1_2_4 hd_b_ch7.appf.tab1_1_1_9_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">not serious</td><td headers="hd_h_ch7.appf.tab1_1_1_1_1 hd_h_ch7.appf.tab1_1_1_2_5 hd_b_ch7.appf.tab1_1_1_9_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">not serious</td><td headers="hd_h_ch7.appf.tab1_1_1_1_1 hd_h_ch7.appf.tab1_1_1_2_6 hd_b_ch7.appf.tab1_1_1_9_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">very serious<sup>b</sup></td><td headers="hd_h_ch7.appf.tab1_1_1_1_1 hd_h_ch7.appf.tab1_1_1_2_7 hd_b_ch7.appf.tab1_1_1_9_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">none</td><td headers="hd_h_ch7.appf.tab1_1_1_1_2 hd_h_ch7.appf.tab1_1_1_2_8 hd_b_ch7.appf.tab1_1_1_9_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:top;">1/33 (3.0%)</td><td headers="hd_h_ch7.appf.tab1_1_1_1_2 hd_h_ch7.appf.tab1_1_1_2_9 hd_b_ch7.appf.tab1_1_1_9_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:top;">0.0%</td><td headers="hd_h_ch7.appf.tab1_1_1_1_3 hd_h_ch7.appf.tab1_1_1_2_10 hd_b_ch7.appf.tab1_1_1_9_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:top;">Peto OR 7.62 (0.15 to 384.01)</td><td headers="hd_h_ch7.appf.tab1_1_1_1_3 hd_h_ch7.appf.tab1_1_1_2_11 hd_b_ch7.appf.tab1_1_1_9_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:top;"><b>30 more per 1000</b> (from 50 fewer to 110 more)</td><td headers="hd_h_ch7.appf.tab1_1_1_1_4 hd_b_ch7.appf.tab1_1_1_9_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:top;">
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<p>⨁◯◯◯</p>
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<p>VERY LOW</p>
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</td><td headers="hd_h_ch7.appf.tab1_1_1_1_5 hd_b_ch7.appf.tab1_1_1_9_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">CRITICAL</td></tr><tr><th headers="hd_h_ch7.appf.tab1_1_1_1_1 hd_h_ch7.appf.tab1_1_1_2_1 hd_h_ch7.appf.tab1_1_1_2_2 hd_h_ch7.appf.tab1_1_1_2_3 hd_h_ch7.appf.tab1_1_1_2_4 hd_h_ch7.appf.tab1_1_1_2_5 hd_h_ch7.appf.tab1_1_1_2_6 hd_h_ch7.appf.tab1_1_1_2_7 hd_h_ch7.appf.tab1_1_1_1_2 hd_h_ch7.appf.tab1_1_1_2_8 hd_h_ch7.appf.tab1_1_1_2_9 hd_h_ch7.appf.tab1_1_1_1_3 hd_h_ch7.appf.tab1_1_1_2_10 hd_h_ch7.appf.tab1_1_1_2_11 hd_h_ch7.appf.tab1_1_1_1_4 hd_h_ch7.appf.tab1_1_1_1_5" id="hd_b_ch7.appf.tab1_1_1_11_1" colspan="13" rowspan="1" style="text-align:left;vertical-align:middle;">Achieving normocalcaemia (follow up: range 24 weeks to 28 weeks)</th></tr><tr><td headers="hd_h_ch7.appf.tab1_1_1_1_1 hd_h_ch7.appf.tab1_1_1_2_1 hd_b_ch7.appf.tab1_1_1_11_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">2</td><td headers="hd_h_ch7.appf.tab1_1_1_1_1 hd_h_ch7.appf.tab1_1_1_2_2 hd_b_ch7.appf.tab1_1_1_11_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">randomised trials</td><td headers="hd_h_ch7.appf.tab1_1_1_1_1 hd_h_ch7.appf.tab1_1_1_2_3 hd_b_ch7.appf.tab1_1_1_11_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">very serious<sup>a</sup></td><td headers="hd_h_ch7.appf.tab1_1_1_1_1 hd_h_ch7.appf.tab1_1_1_2_4 hd_b_ch7.appf.tab1_1_1_11_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">not serious</td><td headers="hd_h_ch7.appf.tab1_1_1_1_1 hd_h_ch7.appf.tab1_1_1_2_5 hd_b_ch7.appf.tab1_1_1_11_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">not serious</td><td headers="hd_h_ch7.appf.tab1_1_1_1_1 hd_h_ch7.appf.tab1_1_1_2_6 hd_b_ch7.appf.tab1_1_1_11_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">not serious</td><td headers="hd_h_ch7.appf.tab1_1_1_1_1 hd_h_ch7.appf.tab1_1_1_2_7 hd_b_ch7.appf.tab1_1_1_11_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">none</td><td headers="hd_h_ch7.appf.tab1_1_1_1_2 hd_h_ch7.appf.tab1_1_1_2_8 hd_b_ch7.appf.tab1_1_1_11_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:top;">54/73 (74.0%)</td><td headers="hd_h_ch7.appf.tab1_1_1_1_2 hd_h_ch7.appf.tab1_1_1_2_9 hd_b_ch7.appf.tab1_1_1_11_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:top;">2.6%</td><td headers="hd_h_ch7.appf.tab1_1_1_1_3 hd_h_ch7.appf.tab1_1_1_2_10 hd_b_ch7.appf.tab1_1_1_11_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:top;"><b>RR 21.28</b> (6.29 to 71.99)</td><td headers="hd_h_ch7.appf.tab1_1_1_1_3 hd_h_ch7.appf.tab1_1_1_2_11 hd_b_ch7.appf.tab1_1_1_11_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:top;"><b>527 more per 1,000</b> (from 138 more to 1,000 more)</td><td headers="hd_h_ch7.appf.tab1_1_1_1_4 hd_b_ch7.appf.tab1_1_1_11_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:top;">
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<p>⨁⨁◯◯</p>
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<p>LOW</p>
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</td><td headers="hd_h_ch7.appf.tab1_1_1_1_5 hd_b_ch7.appf.tab1_1_1_11_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">IMPORTANT</td></tr><tr><th headers="hd_h_ch7.appf.tab1_1_1_1_1 hd_h_ch7.appf.tab1_1_1_2_1 hd_h_ch7.appf.tab1_1_1_2_2 hd_h_ch7.appf.tab1_1_1_2_3 hd_h_ch7.appf.tab1_1_1_2_4 hd_h_ch7.appf.tab1_1_1_2_5 hd_h_ch7.appf.tab1_1_1_2_6 hd_h_ch7.appf.tab1_1_1_2_7 hd_h_ch7.appf.tab1_1_1_1_2 hd_h_ch7.appf.tab1_1_1_2_8 hd_h_ch7.appf.tab1_1_1_2_9 hd_h_ch7.appf.tab1_1_1_1_3 hd_h_ch7.appf.tab1_1_1_2_10 hd_h_ch7.appf.tab1_1_1_2_11 hd_h_ch7.appf.tab1_1_1_1_4 hd_h_ch7.appf.tab1_1_1_1_5" id="hd_b_ch7.appf.tab1_1_1_13_1" colspan="13" rowspan="1" style="text-align:left;vertical-align:middle;">Lumbar spine BMD Z-score (follow up: 52 weeks; change score)</th></tr><tr><td headers="hd_h_ch7.appf.tab1_1_1_1_1 hd_h_ch7.appf.tab1_1_1_2_1 hd_b_ch7.appf.tab1_1_1_13_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">1</td><td headers="hd_h_ch7.appf.tab1_1_1_1_1 hd_h_ch7.appf.tab1_1_1_2_2 hd_b_ch7.appf.tab1_1_1_13_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">randomised trials</td><td headers="hd_h_ch7.appf.tab1_1_1_1_1 hd_h_ch7.appf.tab1_1_1_2_3 hd_b_ch7.appf.tab1_1_1_13_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">very serious<sup>a</sup></td><td headers="hd_h_ch7.appf.tab1_1_1_1_1 hd_h_ch7.appf.tab1_1_1_2_4 hd_b_ch7.appf.tab1_1_1_13_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">not serious</td><td headers="hd_h_ch7.appf.tab1_1_1_1_1 hd_h_ch7.appf.tab1_1_1_2_5 hd_b_ch7.appf.tab1_1_1_13_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">not serious</td><td headers="hd_h_ch7.appf.tab1_1_1_1_1 hd_h_ch7.appf.tab1_1_1_2_6 hd_b_ch7.appf.tab1_1_1_13_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">serious<sup>b</sup></td><td headers="hd_h_ch7.appf.tab1_1_1_1_1 hd_h_ch7.appf.tab1_1_1_2_7 hd_b_ch7.appf.tab1_1_1_13_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">none</td><td headers="hd_h_ch7.appf.tab1_1_1_1_2 hd_h_ch7.appf.tab1_1_1_2_8 hd_b_ch7.appf.tab1_1_1_13_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">40</td><td headers="hd_h_ch7.appf.tab1_1_1_1_2 hd_h_ch7.appf.tab1_1_1_2_9 hd_b_ch7.appf.tab1_1_1_13_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">38</td><td headers="hd_h_ch7.appf.tab1_1_1_1_3 hd_h_ch7.appf.tab1_1_1_2_10 hd_b_ch7.appf.tab1_1_1_13_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:top;">-</td><td headers="hd_h_ch7.appf.tab1_1_1_1_3 hd_h_ch7.appf.tab1_1_1_2_11 hd_b_ch7.appf.tab1_1_1_13_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:top;">MD <b>0.03 lower</b> (0.14 lower to 0.08 higher)</td><td headers="hd_h_ch7.appf.tab1_1_1_1_4 hd_b_ch7.appf.tab1_1_1_13_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:top;">
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<p>⨁◯◯◯</p>
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<p>VERY LOW</p>
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</td><td headers="hd_h_ch7.appf.tab1_1_1_1_5 hd_b_ch7.appf.tab1_1_1_13_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">IMPORTANT</td></tr><tr><th headers="hd_h_ch7.appf.tab1_1_1_1_1 hd_h_ch7.appf.tab1_1_1_2_1 hd_h_ch7.appf.tab1_1_1_2_2 hd_h_ch7.appf.tab1_1_1_2_3 hd_h_ch7.appf.tab1_1_1_2_4 hd_h_ch7.appf.tab1_1_1_2_5 hd_h_ch7.appf.tab1_1_1_2_6 hd_h_ch7.appf.tab1_1_1_2_7 hd_h_ch7.appf.tab1_1_1_1_2 hd_h_ch7.appf.tab1_1_1_2_8 hd_h_ch7.appf.tab1_1_1_2_9 hd_h_ch7.appf.tab1_1_1_1_3 hd_h_ch7.appf.tab1_1_1_2_10 hd_h_ch7.appf.tab1_1_1_2_11 hd_h_ch7.appf.tab1_1_1_1_4 hd_h_ch7.appf.tab1_1_1_1_5" id="hd_b_ch7.appf.tab1_1_1_15_1" colspan="13" rowspan="1" style="text-align:left;vertical-align:middle;">Distal radius BMD Z-score (follow up: 52 weeks; change score)</th></tr><tr><td headers="hd_h_ch7.appf.tab1_1_1_1_1 hd_h_ch7.appf.tab1_1_1_2_1 hd_b_ch7.appf.tab1_1_1_15_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">1</td><td headers="hd_h_ch7.appf.tab1_1_1_1_1 hd_h_ch7.appf.tab1_1_1_2_2 hd_b_ch7.appf.tab1_1_1_15_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">randomised trials</td><td headers="hd_h_ch7.appf.tab1_1_1_1_1 hd_h_ch7.appf.tab1_1_1_2_3 hd_b_ch7.appf.tab1_1_1_15_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">very serious<sup>a</sup></td><td headers="hd_h_ch7.appf.tab1_1_1_1_1 hd_h_ch7.appf.tab1_1_1_2_4 hd_b_ch7.appf.tab1_1_1_15_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">not serious</td><td headers="hd_h_ch7.appf.tab1_1_1_1_1 hd_h_ch7.appf.tab1_1_1_2_5 hd_b_ch7.appf.tab1_1_1_15_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">not serious</td><td headers="hd_h_ch7.appf.tab1_1_1_1_1 hd_h_ch7.appf.tab1_1_1_2_6 hd_b_ch7.appf.tab1_1_1_15_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">serious<sup>b</sup></td><td headers="hd_h_ch7.appf.tab1_1_1_1_1 hd_h_ch7.appf.tab1_1_1_2_7 hd_b_ch7.appf.tab1_1_1_15_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">none</td><td headers="hd_h_ch7.appf.tab1_1_1_1_2 hd_h_ch7.appf.tab1_1_1_2_8 hd_b_ch7.appf.tab1_1_1_15_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:top;">40</td><td headers="hd_h_ch7.appf.tab1_1_1_1_2 hd_h_ch7.appf.tab1_1_1_2_9 hd_b_ch7.appf.tab1_1_1_15_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">38</td><td headers="hd_h_ch7.appf.tab1_1_1_1_3 hd_h_ch7.appf.tab1_1_1_2_10 hd_b_ch7.appf.tab1_1_1_15_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:top;">-</td><td headers="hd_h_ch7.appf.tab1_1_1_1_3 hd_h_ch7.appf.tab1_1_1_2_11 hd_b_ch7.appf.tab1_1_1_15_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:top;">MD <b>0.04 lower</b> (0.19 lower to 0.11 higher)</td><td headers="hd_h_ch7.appf.tab1_1_1_1_4 hd_b_ch7.appf.tab1_1_1_15_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:top;">
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<p>⨁◯◯◯</p>
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<p>VERY LOW</p>
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</td><td headers="hd_h_ch7.appf.tab1_1_1_1_5 hd_b_ch7.appf.tab1_1_1_15_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">IMPORTANT</td></tr><tr><th headers="hd_h_ch7.appf.tab1_1_1_1_1 hd_h_ch7.appf.tab1_1_1_2_1 hd_h_ch7.appf.tab1_1_1_2_2 hd_h_ch7.appf.tab1_1_1_2_3 hd_h_ch7.appf.tab1_1_1_2_4 hd_h_ch7.appf.tab1_1_1_2_5 hd_h_ch7.appf.tab1_1_1_2_6 hd_h_ch7.appf.tab1_1_1_2_7 hd_h_ch7.appf.tab1_1_1_1_2 hd_h_ch7.appf.tab1_1_1_2_8 hd_h_ch7.appf.tab1_1_1_2_9 hd_h_ch7.appf.tab1_1_1_1_3 hd_h_ch7.appf.tab1_1_1_2_10 hd_h_ch7.appf.tab1_1_1_2_11 hd_h_ch7.appf.tab1_1_1_1_4 hd_h_ch7.appf.tab1_1_1_1_5" id="hd_b_ch7.appf.tab1_1_1_17_1" colspan="13" rowspan="1" style="text-align:left;vertical-align:middle;">Adverse events at <6 months (follow up: 22 days)</th></tr><tr><td headers="hd_h_ch7.appf.tab1_1_1_1_1 hd_h_ch7.appf.tab1_1_1_2_1 hd_b_ch7.appf.tab1_1_1_17_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">1</td><td headers="hd_h_ch7.appf.tab1_1_1_1_1 hd_h_ch7.appf.tab1_1_1_2_2 hd_b_ch7.appf.tab1_1_1_17_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">randomised trials</td><td headers="hd_h_ch7.appf.tab1_1_1_1_1 hd_h_ch7.appf.tab1_1_1_2_3 hd_b_ch7.appf.tab1_1_1_17_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">very serious<sup>a</sup></td><td headers="hd_h_ch7.appf.tab1_1_1_1_1 hd_h_ch7.appf.tab1_1_1_2_4 hd_b_ch7.appf.tab1_1_1_17_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">not serious</td><td headers="hd_h_ch7.appf.tab1_1_1_1_1 hd_h_ch7.appf.tab1_1_1_2_5 hd_b_ch7.appf.tab1_1_1_17_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">not serious</td><td headers="hd_h_ch7.appf.tab1_1_1_1_1 hd_h_ch7.appf.tab1_1_1_2_6 hd_b_ch7.appf.tab1_1_1_17_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">very serious<sup>b</sup></td><td headers="hd_h_ch7.appf.tab1_1_1_1_1 hd_h_ch7.appf.tab1_1_1_2_7 hd_b_ch7.appf.tab1_1_1_17_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">none</td><td headers="hd_h_ch7.appf.tab1_1_1_1_2 hd_h_ch7.appf.tab1_1_1_2_8 hd_b_ch7.appf.tab1_1_1_17_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">9/16 (56.3%)</td><td headers="hd_h_ch7.appf.tab1_1_1_1_2 hd_h_ch7.appf.tab1_1_1_2_9 hd_b_ch7.appf.tab1_1_1_17_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">66.7%</td><td headers="hd_h_ch7.appf.tab1_1_1_1_3 hd_h_ch7.appf.tab1_1_1_2_10 hd_b_ch7.appf.tab1_1_1_17_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;"><b>RR 0.84</b> (0.41 to 1.72)</td><td headers="hd_h_ch7.appf.tab1_1_1_1_3 hd_h_ch7.appf.tab1_1_1_2_11 hd_b_ch7.appf.tab1_1_1_17_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;"><b>107 fewer per 1,000</b> (from 394 fewer to 480 more)</td><td headers="hd_h_ch7.appf.tab1_1_1_1_4 hd_b_ch7.appf.tab1_1_1_17_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>⨁◯◯◯</p>
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<p>VERY LOW</p>
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</td><td headers="hd_h_ch7.appf.tab1_1_1_1_5 hd_b_ch7.appf.tab1_1_1_17_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;"></td></tr><tr><th headers="hd_h_ch7.appf.tab1_1_1_1_1 hd_h_ch7.appf.tab1_1_1_2_1 hd_h_ch7.appf.tab1_1_1_2_2 hd_h_ch7.appf.tab1_1_1_2_3 hd_h_ch7.appf.tab1_1_1_2_4 hd_h_ch7.appf.tab1_1_1_2_5 hd_h_ch7.appf.tab1_1_1_2_6 hd_h_ch7.appf.tab1_1_1_2_7 hd_h_ch7.appf.tab1_1_1_1_2 hd_h_ch7.appf.tab1_1_1_2_8 hd_h_ch7.appf.tab1_1_1_2_9 hd_h_ch7.appf.tab1_1_1_1_3 hd_h_ch7.appf.tab1_1_1_2_10 hd_h_ch7.appf.tab1_1_1_2_11 hd_h_ch7.appf.tab1_1_1_1_4 hd_h_ch7.appf.tab1_1_1_1_5" id="hd_b_ch7.appf.tab1_1_1_19_1" colspan="13" rowspan="1" style="text-align:left;vertical-align:middle;">Adverse events (follow up: range 28 weeks to 52 weeks)<sup>e</sup></th></tr><tr><td headers="hd_h_ch7.appf.tab1_1_1_1_1 hd_h_ch7.appf.tab1_1_1_2_1 hd_b_ch7.appf.tab1_1_1_19_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">2</td><td headers="hd_h_ch7.appf.tab1_1_1_1_1 hd_h_ch7.appf.tab1_1_1_2_2 hd_b_ch7.appf.tab1_1_1_19_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">randomised trials</td><td headers="hd_h_ch7.appf.tab1_1_1_1_1 hd_h_ch7.appf.tab1_1_1_2_3 hd_b_ch7.appf.tab1_1_1_19_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">very serious<sup>a</sup></td><td headers="hd_h_ch7.appf.tab1_1_1_1_1 hd_h_ch7.appf.tab1_1_1_2_4 hd_b_ch7.appf.tab1_1_1_19_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">not serious</td><td headers="hd_h_ch7.appf.tab1_1_1_1_1 hd_h_ch7.appf.tab1_1_1_2_5 hd_b_ch7.appf.tab1_1_1_19_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">not serious</td><td headers="hd_h_ch7.appf.tab1_1_1_1_1 hd_h_ch7.appf.tab1_1_1_2_6 hd_b_ch7.appf.tab1_1_1_19_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">serious<sup>b</sup></td><td headers="hd_h_ch7.appf.tab1_1_1_1_1 hd_h_ch7.appf.tab1_1_1_2_7 hd_b_ch7.appf.tab1_1_1_19_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">none</td><td headers="hd_h_ch7.appf.tab1_1_1_1_2 hd_h_ch7.appf.tab1_1_1_2_8 hd_b_ch7.appf.tab1_1_1_19_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">35/73 (47.9%)</td><td headers="hd_h_ch7.appf.tab1_1_1_1_2 hd_h_ch7.appf.tab1_1_1_2_9 hd_b_ch7.appf.tab1_1_1_19_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:top;">37.3%</td><td headers="hd_h_ch7.appf.tab1_1_1_1_3 hd_h_ch7.appf.tab1_1_1_2_10 hd_b_ch7.appf.tab1_1_1_19_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:top;"><b>RR 1.36</b> (0.98 to 1.90)</td><td headers="hd_h_ch7.appf.tab1_1_1_1_3 hd_h_ch7.appf.tab1_1_1_2_11 hd_b_ch7.appf.tab1_1_1_19_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:top;"><b>134 more per 1,000</b> (from 7 fewer to 336 more)</td><td headers="hd_h_ch7.appf.tab1_1_1_1_4 hd_b_ch7.appf.tab1_1_1_19_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:top;">
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<p>⨁◯◯◯</p>
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<p>VERY LOW</p>
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</td><td headers="hd_h_ch7.appf.tab1_1_1_1_5 hd_b_ch7.appf.tab1_1_1_19_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">IMPORTANT</td></tr><tr><th headers="hd_h_ch7.appf.tab1_1_1_1_1 hd_h_ch7.appf.tab1_1_1_2_1 hd_h_ch7.appf.tab1_1_1_2_2 hd_h_ch7.appf.tab1_1_1_2_3 hd_h_ch7.appf.tab1_1_1_2_4 hd_h_ch7.appf.tab1_1_1_2_5 hd_h_ch7.appf.tab1_1_1_2_6 hd_h_ch7.appf.tab1_1_1_2_7 hd_h_ch7.appf.tab1_1_1_1_2 hd_h_ch7.appf.tab1_1_1_2_8 hd_h_ch7.appf.tab1_1_1_2_9 hd_h_ch7.appf.tab1_1_1_1_3 hd_h_ch7.appf.tab1_1_1_2_10 hd_h_ch7.appf.tab1_1_1_2_11 hd_h_ch7.appf.tab1_1_1_1_4 hd_h_ch7.appf.tab1_1_1_1_5" id="hd_b_ch7.appf.tab1_1_1_21_1" colspan="13" rowspan="1" style="text-align:left;vertical-align:middle;">Serious adverse events (follow up: 28 weeks)</th></tr><tr><td headers="hd_h_ch7.appf.tab1_1_1_1_1 hd_h_ch7.appf.tab1_1_1_2_1 hd_b_ch7.appf.tab1_1_1_21_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">1</td><td headers="hd_h_ch7.appf.tab1_1_1_1_1 hd_h_ch7.appf.tab1_1_1_2_2 hd_b_ch7.appf.tab1_1_1_21_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">randomised trials</td><td headers="hd_h_ch7.appf.tab1_1_1_1_1 hd_h_ch7.appf.tab1_1_1_2_3 hd_b_ch7.appf.tab1_1_1_21_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">very serious<sup>a</sup></td><td headers="hd_h_ch7.appf.tab1_1_1_1_1 hd_h_ch7.appf.tab1_1_1_2_4 hd_b_ch7.appf.tab1_1_1_21_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">not serious</td><td headers="hd_h_ch7.appf.tab1_1_1_1_1 hd_h_ch7.appf.tab1_1_1_2_5 hd_b_ch7.appf.tab1_1_1_21_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">not serious</td><td headers="hd_h_ch7.appf.tab1_1_1_1_1 hd_h_ch7.appf.tab1_1_1_2_6 hd_b_ch7.appf.tab1_1_1_21_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">very serious<sup>b</sup></td><td headers="hd_h_ch7.appf.tab1_1_1_1_1 hd_h_ch7.appf.tab1_1_1_2_7 hd_b_ch7.appf.tab1_1_1_21_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">none</td><td headers="hd_h_ch7.appf.tab1_1_1_1_2 hd_h_ch7.appf.tab1_1_1_2_8 hd_b_ch7.appf.tab1_1_1_21_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:top;">3/33 (9.1%)</td><td headers="hd_h_ch7.appf.tab1_1_1_1_2 hd_h_ch7.appf.tab1_1_1_2_9 hd_b_ch7.appf.tab1_1_1_21_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:top;">11.8%</td><td headers="hd_h_ch7.appf.tab1_1_1_1_3 hd_h_ch7.appf.tab1_1_1_2_10 hd_b_ch7.appf.tab1_1_1_21_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:top;"><b>RR 0.77</b> (0.19 to 3.19)</td><td headers="hd_h_ch7.appf.tab1_1_1_1_3 hd_h_ch7.appf.tab1_1_1_2_11 hd_b_ch7.appf.tab1_1_1_21_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:top;"><b>27 fewer per 1,000</b> (from 95 fewer to 258 more)</td><td headers="hd_h_ch7.appf.tab1_1_1_1_4 hd_b_ch7.appf.tab1_1_1_21_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:top;">
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<p>⨁◯◯◯</p>
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<p>VERY LOW</p>
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</td><td headers="hd_h_ch7.appf.tab1_1_1_1_5 hd_b_ch7.appf.tab1_1_1_21_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">IMPORTANT</td></tr></tbody></table></div><div class="tblwrap-foot"><div><dl class="temp-labeled-list small"><dl class="bkr_refwrap"><dt>a</dt><dd><div id="ch7.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></dl><dl class="bkr_refwrap"><dt>b</dt><dd><div id="ch7.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></dl><dl class="bkr_refwrap"><dt>c</dt><dd><div id="ch7.appf.tab1_3"><p class="no_margin">Established MIDs used for SF36</p></div></dd></dl><dl class="bkr_refwrap"><dt>d</dt><dd><div id="ch7.appf.tab1_4"><p class="no_margin">Fatal event in the study was considered as unrelated to the intervention. One patient died due to decreased appetite (anorexia). The patient had a history of dementia and was taking concurrent medications including haloperidol.</p></div></dd></dl><dl class="bkr_refwrap"><dt>e</dt><dd><div id="ch7.appf.tab1_5"><p class="no_margin">Actual outcome reported in one study was the number of people withdrawing due to adverse events (not the total number of people having adverse events). The other study reported the total number of people having adverse events, with the most frequent events being nausea and muscle spasms.</p></div></dd></dl></dl></div></div></div></article><article data-type="fig" id="figobch7appgfig1"><div id="ch7.appg.fig1" class="figure bk_fig"><div class="graphic"><a href="/core/lw/2.0/html/tileshop_pmc/tileshop_pmc_inline.html?title=Figure%2013.%20Flow%20chart%20of%20health%20economic%20study%20selection%20for%20the%20guideline.&p=BOOKS&id=577894_ch7appgf1.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 data-src="/books/NBK577894/bin/ch7appgf1.jpg" alt="Figure 13. 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 13</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></article><article data-type="table-wrap" id="figobch7appitab1"><div id="ch7.appi.tab1" class="table"><h3><span class="label">Table 10</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/NBK577894/table/ch7.appi.tab1/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__ch7.appi.tab1_lrgtbl__"><table><thead><tr><th id="hd_h_ch7.appi.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Study</th><th id="hd_h_ch7.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_ch7.appi.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Akbaba 2013<a class="bibr" href="#ch7.ref1" rid="ch7.ref1"><sup>1</sup></a></td><td headers="hd_h_ch7.appi.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Incorrect comparator</td></tr><tr><td headers="hd_h_ch7.appi.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Brardi 2015<a class="bibr" href="#ch7.ref2" rid="ch7.ref2"><sup>2</sup></a></td><td headers="hd_h_ch7.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_ch7.appi.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Casez 2003<a class="bibr" href="#ch7.ref3" rid="ch7.ref3"><sup>3</sup></a></td><td headers="hd_h_ch7.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_ch7.appi.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Cesareo 2017<a class="bibr" href="#ch7.ref4" rid="ch7.ref4"><sup>4</sup></a></td><td headers="hd_h_ch7.appi.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Incorrect interventions (bisphosphonates)</td></tr><tr><td headers="hd_h_ch7.appi.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Chow 2003<a class="bibr" href="#ch7.ref5" rid="ch7.ref5"><sup>5</sup></a></td><td headers="hd_h_ch7.appi.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Incorrect interventions (bisphosphonates)</td></tr><tr><td headers="hd_h_ch7.appi.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Hamdy 1987<a class="bibr" href="#ch7.ref6" rid="ch7.ref6"><sup>6</sup></a></td><td headers="hd_h_ch7.appi.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Incorrect interventions (bisphosphonates)</td></tr><tr><td headers="hd_h_ch7.appi.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Hassani 2001<a class="bibr" href="#ch7.ref7" rid="ch7.ref7"><sup>7</sup></a></td><td headers="hd_h_ch7.appi.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Incorrect interventions (bisphosphonates)</td></tr><tr><td headers="hd_h_ch7.appi.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Horiuchi 2002<a class="bibr" href="#ch7.ref8" rid="ch7.ref8"><sup>8</sup></a></td><td headers="hd_h_ch7.appi.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Incorrect interventions (bisphosphonates)</td></tr><tr><td headers="hd_h_ch7.appi.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Khan 2004<a class="bibr" href="#ch7.ref13" rid="ch7.ref13"><sup>13</sup></a></td><td headers="hd_h_ch7.appi.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Incorrect interventions (bisphosphonates)</td></tr><tr><td headers="hd_h_ch7.appi.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Khan 2009<a class="bibr" href="#ch7.ref12" rid="ch7.ref12"><sup>12</sup></a></td><td headers="hd_h_ch7.appi.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Incorrect interventions (bisphosphonates)</td></tr><tr><td headers="hd_h_ch7.appi.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Khan 2014<a class="bibr" href="#ch7.ref11" rid="ch7.ref11"><sup>11</sup></a></td><td headers="hd_h_ch7.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_ch7.appi.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Martin 2010<a class="bibr" href="#ch7.ref14" rid="ch7.ref14"><sup>14</sup></a></td><td headers="hd_h_ch7.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_ch7.appi.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Narayan 2007<a class="bibr" href="#ch7.ref15" rid="ch7.ref15"><sup>15</sup></a></td><td headers="hd_h_ch7.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_ch7.appi.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Parker 2002<a class="bibr" href="#ch7.ref17" rid="ch7.ref17"><sup>17</sup></a></td><td headers="hd_h_ch7.appi.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Incorrect interventions (bisphosphonates)</td></tr><tr><td headers="hd_h_ch7.appi.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Peacock 2009<a class="bibr" href="#ch7.ref20" rid="ch7.ref20"><sup>20</sup></a></td><td headers="hd_h_ch7.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_ch7.appi.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Peacock 2011<a class="bibr" href="#ch7.ref18" rid="ch7.ref18"><sup>18</sup></a></td><td headers="hd_h_ch7.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_ch7.appi.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Reasner 1993<a class="bibr" href="#ch7.ref21" rid="ch7.ref21"><sup>21</sup></a></td><td headers="hd_h_ch7.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_ch7.appi.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Rossini 2001<a class="bibr" href="#ch7.ref22" rid="ch7.ref22"><sup>22</sup></a></td><td headers="hd_h_ch7.appi.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Incorrect interventions (bisphosphonates)</td></tr><tr><td headers="hd_h_ch7.appi.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Sankaran 2010<a class="bibr" href="#ch7.ref23" rid="ch7.ref23"><sup>23</sup></a></td><td headers="hd_h_ch7.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_ch7.appi.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Schwarz 2014<a class="bibr" href="#ch7.ref24" rid="ch7.ref24"><sup>24</sup></a></td><td headers="hd_h_ch7.appi.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Non-comparative observational study (PRIMARA study)</td></tr><tr><td headers="hd_h_ch7.appi.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Szczech 2004<a class="bibr" href="#ch7.ref27" rid="ch7.ref27"><sup>27</sup></a></td><td headers="hd_h_ch7.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></article></div><div id="jr-scripts"><script src="/corehtml/pmc/jatsreader/ptpmc_3.22/js/libs.min.js"> </script><script src="/corehtml/pmc/jatsreader/ptpmc_3.22/js/jr.min.js"> </script></div></div>
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