NICE

NICE
  • 文章类型: Journal Article
    目的:本研究的目的是分析美国国家健康与护理卓越研究所(NICE)在过去十年中对非小细胞肺癌(NSCLC)治疗进行技术评估的趋势。
    方法:对2012年至2022年在线NICE数据库中NSCLC药物的单一技术评估进行了系统搜索。使用的搜索词是“非小细胞肺癌”,和“非小细胞肺癌”。正在开发或终止的评估以及多个技术评估被认为超出了范围。
    结果:在30份纳入非小细胞肺癌靶向治疗和免疫治疗的评估中,NICE共纳入了41个不同适应症或亚组的53个不同比较者.分区生存模型是最常用的,通常包括三个健康状态和长达30年的时间范围。在整个十年中,间接比较的使用很高,并且随着时间的推移变得更加成熟和复杂。在所有的评估中,90%的人积极推荐在英国使用的治疗方法。
    结论:由于靶向治疗和免疫疗法的出现,随着时间的推移,技术评估变得更加复杂,导致多个不同的适应症,需要纳入评估的亚群和比较者。分区生存分析(PartSA)模型成为非小细胞肺癌的基石,在长达30年的时间范围内,随着时间的推移,间接治疗比较的方法变得更加成熟。大多数评估结果都提出了积极的偿还建议。
    OBJECTIVE: The aim of this study is to analyse the trends in technology appraisals for non-small cell lung cancer (NSCLC) treatments performed by the National Institute for Health and Care Excellence (NICE) over the last ten years.
    METHODS: A systematic search was conducted for single technology appraisals of NSCLC drugs in the online NICE database from 2012 to 2022. Search terms used were \'non small cell lung cancer\', and \'NSCLC\'. Appraisals that were under development or terminated as well as multiple technology appraisals were considered out of scope.
    RESULTS: In the 30 included appraisals for targeted therapies and immunotherapies within NSCLC, a total of 53 different comparators were included by NICE for 41 assorted indications or subgroups. Partitioned survival models were most frequently used, often including three health states and time horizons of up to 30 years. Throughout the decade the use of indirect comparisons was high and became more established and complex over time. Of all appraisals, 90% positively recommended the treatment for use in the UK.
    CONCLUSIONS: Technology appraisals became more complex over time due to the emergence of targeted therapies and immunotherapies, leading to multiple different indications, subpopulations and comparators that needed to be included in appraisals. Partitioned Survival Analysis (PartSA) models became the cornerstone within NSCLC, with time horizons up to 30 years and over time methods for indirect treatment comparisons became more established. The majority of the appraisals resulted in a positive recommendation for reimbursement.
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  • 文章类型: Editorial
    暂无摘要。
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  • 文章类型: Journal Article
    房颤评估和管理的临床指南强调考虑患者偏好的重要性。对美国国家健康与社会护理卓越研究所(NICE)的详细检查提出了严重的疑问,即这些建议是否嵌入了有关优先考虑患者的关键权衡的偏好;不要强调需要向他们提供有关他们成为知情患者所必需的选择后果的信息;并将其描述为“一致”或“不一致”,而不是独立有效。美国和欧洲的指导方针在这些方面没有显著差异。
    Clinical guidelines for the assessment and management of atrial fibrillation emphasize the importance of taking the patient\'s preferences into account. A detailed examination of those from the National Institute for Excellence in Health and Social Care (NICE) raise serious questions about whether the recommendations embed preferences about crucial trade-offs that pre-empt those of the patient; do not stress the need to provide them with the information on option consequences necessary for them to become an informed patient; and characterise them as \'concordant\' or \'discordant\' rather than independently valid. American and European guidelines do not differ significantly in these respects.
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  • 文章类型: Journal Article
    目的:在大多数使用Kudo分类的试验中,窄带成像(NBI)在溃疡性结肠炎(UC)的内镜监测中的诊断准确性令人失望。我们的目的是比较NBI在UC病变表征中的表现,当根据三种不同的分类应用时(NICE,Kudo,Kudo-IBD)。
    方法:在前瞻性中,现实生活中的研究,根据NICE,在使用NBI(Exera-IICV-180)对UC进行连续监测结肠镜检查期间发现的所有可见病变均被分类为疑似或非疑似瘤形成,Kudo和Kudo-IBD标准。灵敏度(SE),特异性(SP),计算三个分类的正(+LR)和负(-LR)似然比,使用组织学作为参考标准。
    结果:394个病灶(平均大小6毫米,范围2-40毫米)对84例患者进行了分析。21个肿瘤(5%),49例增生(12%),发现了324个炎症(82%)病变。NICE的诊断准确性,Kudo和Kudo-IBD分类是,分别为:SE76%-71%-86%;SP55-69%-79%(p<0.05Kudo-IBDvs.Kudo和NICE);+LR1.69-2.34-4.15(p<0.05Kudo-IBDvs.工藤和NICE);-LR0.43-0.41-0.18。
    结论:如果与普通人群的常规分类一起使用,NBI在UC肿瘤和非肿瘤性病变的鉴别中的诊断准确性较低,但改良后的UC特异性Kudo分类明显更好。
    OBJECTIVE: The diagnostic accuracy of Narrow Band Imaging (NBI) in the endoscopic surveillance of ulcerative colitis (UC) has been disappointing in most trials which used the Kudo classification. We aim to compare the performance of NBI in the lesion characterization of UC, when applied according to three different classifications (NICE, Kudo, Kudo-IBD).
    METHODS: In a prospective, real-life study, all visible lesions found during consecutive surveillance colonoscopies with NBI (Exera-II CV-180) for UC were classified as suspected or non-suspected for neoplasia according to the NICE, Kudo and Kudo-IBD criteria. The sensitivity (SE), specificity (SP), positive (+LR) and negative (-LR) likelihood ratios of the three classifications were calculated, using histology as the reference standard.
    RESULTS: 394 lesions (mean size 6 mm, range 2-40 mm) from 84 patients were analysed. Twenty-one neoplastic (5%), 49 hyperplastic (12%), and 324 inflammatory (82%) lesions were found. The diagnostic accuracy of the NICE, Kudo and Kudo-IBD classifications were, respectively: SE 76%-71%-86%; SP 55-69%-79% (p < 0.05 Kudo-IBD vs. both Kudo and NICE); +LR 1.69-2.34-4.15 (p < 0.05 Kudo-IBD vs. both Kudo and NICE); -LR 0.43-0.41-0.18.
    CONCLUSIONS: The diagnostic accuracy of NBI in the differentiation of neoplastic and non-neoplastic lesions in UC is low if used with conventional classifications of the general population, but it is significantly better with the modified Kudo classification specific for UC.
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  • 文章类型: Journal Article
    背景:研究的目的是:1)评估对2023年美国国家健康与护理卓越研究所(NICE)新标准的满意度,该标准用于选择全髋关节置换术(THA)而不是半髋关节置换术(HA)和治疗移位的髋关节囊内骨折的手术建议;2)描述为什么不符合NICE标准时进行THA;3)确定对这些指南的满意度是否与改善相关。
    方法:对2010年至2022年在一个三级学术中心接受THA治疗的移位性髋关节囊内骨折患者进行回顾性分析。审查了术前患者特征,以确定THA的适应症是否符合NICE标准。操作详情,围手术期并发症,重新操作,并记录手术后12个月内的关节翻修术.
    结果:使用了196例患者(63%为女性;年龄67±10岁)的数据。有161个THA(82.1%)满足NICE标准。当不符合NICE标准(n=35)时,进行THA的两个最常见原因包括术前影像学骨关节炎(Tönnnis等级≥2;48.6%)和患者年龄降低(<65岁;31.5%)。对NICE标准的满意度与较少的围手术期并发症相关(0.6对37.1%;P<0.001)。再次手术(0.6对31.4%;P<0.001),和修订(0.6对28.6%;P<0.001)。最常见的翻修原因是假体周围骨折,可能继发于使用非骨水泥股骨柄(196中的171,87.2%)。
    结论:对新NICE标准的满意度与改善围手术期结局相关。有必要进行进一步的研究,以确定在选择患者时是否需要考虑先前存在的髋关节骨关节炎和较年轻的年龄。
    BACKGROUND: The objectives of the study were to: (1) evaluate satisfaction with the new 2023 National Institute of Health and Care Excellence (NICE) criteria for selecting total hip arthroplasty (THA) over hemiarthroplasty and surgical recommendations for treatment of displaced intracapsular hip fractures; (2) describe why THA is performed when NICE criteria are not met; and (3) determine whether satisfaction with these guidelines is associated with improved outcomes.
    METHODS: A retrospective chart review of patients who had a displaced intracapsular hip fracture treated with THA at a single tertiary academic center between 2010 and 2022 was performed. Preoperative patient characteristics were reviewed to determine if the indication for THA met NICE criteria. Operative details, perioperative complications, reoperation, and revision arthroplasty within 12 months of surgery were recorded.
    RESULTS: Data from 196 patients (63% women; age 67 ± 10 years) were used. There were 161 THAs (82.1%) that satisfied NICE criteria. The 2 most common reasons for performing a THA when NICE criteria were not met (n = 35) included preoperative radiographic osteoarthritis (Tönnis grade ≥ 2; 48.6%) and decreased patient age (< 65 years; 31.5%). Satisfaction with the NICE criteria was associated with fewer perioperative complications (0.6 versus 37.1%; P < .001), reoperations (0.6 versus 31.4%; P < .001), and revisions (0.6 versus 28.6%; P < .001). The most common reason for revision was periprosthetic fracture, possibly secondary to the use of uncemented femoral stems (171 of 196, 87.2%).
    CONCLUSIONS: Satisfaction with the new NICE criteria is associated with improved perioperative outcomes. Further studies are necessary to determine if preexisting hip osteoarthritis and younger age merit consideration in patient selection.
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  • 文章类型: Journal Article
    背景:轻度高血糖与出生体重增加有关,但与其他新生儿结局的关系存在争议。我们旨在使用不同的口服葡萄糖耐量试验(OGTT)阈值研究未经治疗的轻度高血糖的新生儿结局。
    方法:这项基于注册的研究包括2009年在芬兰六家分娩医院参加75g2小时OGTT的所有(n=4,939)单胎孕妇。芬兰GDM的诊断截止日期为空腹≥5.3,1h≥10.0或2h葡萄糖≥8.6mmol/L。不符合这些标准但符合国际糖尿病和妊娠研究组协会(IADPSG)标准(空腹5.1-5.2mmol/L和/或2小时血糖8.5mmol/L,n=509)或美国国立卫生与临床卓越研究所(NICE)标准(2小时葡萄糖7.8-8.5mmol/L,n=166)被认为是轻度未经治疗的高血糖症。符合芬兰标准和IADPSG或NICE标准的女性被视为GDM治疗组(分别为n=1292和n=612)。根据所有标准(空腹血糖<5.1mmol/L,1小时葡萄糖<10.0mmol/L,2小时葡萄糖<8.5mmol/L,n=3031)。将未治疗的轻度高血糖组与对照组和治疗的GDM组进行比较。主要结局-新生儿不良结局的复合,包括新生儿低血糖,高胆红素血症,出生创伤或围产期死亡率-使用多变量逻辑回归分析。
    结果:与对照组相比,未经治疗的轻度高血糖的新生儿不良结局的风险没有增加(使用IADPSG标准的调整比值比[aOR]:1.01,95%置信区间[CI]:0.71-1.44;使用NICE标准的aOR:1.05,95%CI:0.60-1.85)。与治疗的IADPSG(aOR0.38,95%CI0.27-0.53)或治疗的NICE组(aOR0.32,95%CI0.18-0.57)相比,风险较低。
    结论:与正常血糖对照组相比,轻度未经治疗的高血糖组新生儿不良结局的风险没有增加,并且低于接受治疗的GDM组。空腹时5.3mmol/L和2h时8.6mmol/L的OGTT截止值似乎足以识别临床相关的GDM。不排除有不良后果风险的新生儿。
    BACKGROUND: Mild hyperglycaemia is associated with increased birth weight but association with other neonatal outcomes is controversial. We aimed to study neonatal outcomes in untreated mild hyperglycaemia using different oral glucose tolerance test (OGTT) thresholds.
    METHODS: This register-based study included all (n = 4,939) singleton pregnant women participating a 75 g 2-h OGTT in six delivery hospitals in Finland in 2009. Finnish diagnostic cut-offs for GDM were fasting ≥ 5.3, 1 h ≥ 10.0 or 2-h glucose ≥ 8.6 mmol/L. Women who did not meet these criteria but met the International Association of the Diabetes and Pregnancy Study Groups (IADPSG) criteria (fasting 5.1-5.2 mmol/L and/or 2-h glucose 8.5 mmol/L, n = 509) or the National Institute for Health and Clinical Excellence (NICE) criteria (2-h glucose 7.8-8.5 mmol/L, n = 166) were considered as mild untreated hyperglycaemia. Women who met both the Finnish criteria and the IADPSG or the NICE criteria were considered as treated GDM groups (n = 1292 and n = 612, respectively). Controls were normoglycaemic according to all criteria (fasting glucose < 5.1 mmol/L, 1-h glucose < 10.0 mmol/L and 2-h glucose < 8.5 mmol/L, n = 3031). Untreated mild hyperglycemia groups were compared to controls and treated GDM groups. The primary outcome - a composite of adverse neonatal outcomes, including neonatal hypoglycaemia, hyperbilirubinaemia, birth trauma or perinatal mortality - was analysed using multivariate logistic regression.
    RESULTS: The risk for the adverse neonatal outcome in untreated mild hyperglycemia was not increased compared to controls (adjusted odds ratio [aOR]: 1.01, 95% confidence interval [CI]: 0.71-1.44, using the IADPSG criteria; aOR: 1.05, 95% CI: 0.60-1.85, using the NICE criteria). The risk was lower compared to the treated IADPSG (aOR 0.38, 95% CI 0.27-0.53) or the treated NICE group (aOR 0.32, 95% CI 0.18-0.57).
    CONCLUSIONS: The risk of adverse neonatal outcomes was not increased in mild untreated hyperglycaemia compared to normoglycaemic controls and was lower than in the treated GDM groups. The OGTT cut-offs of 5.3 mmol/L at fasting and 8.6 mmol/L at 2 h seem to sufficiently identify clinically relevant GDM, without excluding neonates with a risk of adverse outcomes.
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  • 文章类型: Journal Article
    心房颤动(AF)是最常见的持续性心律失常,也是一种日益严重的公共卫生流行病。在英国,超过130万人被诊断为房颤,估计有40万人仍未被诊断。与AF相关的中风占所有中风的四分之一,由于房颤发作通常无症状,通常仍然是房颤的第一个表现。早期诊断和开始口服抗凝治疗,在适当的情况下,可以预防一些血栓栓塞性中风。英国公共卫生部致力于降低房颤相关中风的发生率,并赞助了旨在通过促进可穿戴技术的采用来改善房颤检测的举措。然而,美国国家健康与护理卓越研究所(NICE)在其最近的AF诊断和治疗指南(NG196)中未推荐可穿戴技术.由最新迭代的可穿戴设备生成的单导联心电图(ECG)的诊断准确性非常出色,在许多情况下,优于全科医生对12导联心电图的解释。来自可穿戴设备的高质量ECG明确显示AF可以加快AF检测。否则,确实存在延迟房颤诊断的风险,可能给患者及其家属带来毁灭性后果.
    Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia and a growing public health epidemic. In the UK, over 1.3 million people have a diagnosis of AF and an estimated 400,000 remain undiagnosed. AF-related strokes account for a quarter of all strokes and, as AF episodes are often asymptomatic, are still often the first manifestation of AF. Early diagnosis and initiation of oral anticoagulation, where appropriate, may prevent some of these thromboembolic strokes. Public Health England is committed to decrease the incidence of AF-related strokes and has sponsored initiatives aimed at improving AF detection by promoting the uptake of wearable technologies. However, the National Institute for Health and Care Excellence (NICE) has not recommended wearable technology in their recent AF diagnosis and management guidelines (NG196). Diagnostic accuracy of single-lead electrocardiography (ECG) generated by the latest iteration of wearable devices is excellent and, in many cases, superior to general practitioner interpretation of the 12-lead ECG. High-quality ECG from wearable devices that unequivocally shows AF can expedite AF detection. Otherwise, there is a real risk of delaying AF diagnosis with the potential of devastating consequences for patients and their families.
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  • 文章类型: Journal Article
    2023年,欧洲心脏病学会(ESC)更新了其感染性心内膜炎(IE)指南,强烈支持在高风险患者的侵入性牙科手术(IDP)之前预防抗生素(AP)。美国心脏协会(AHA)同意这一观点,并在2021年指南中重申AP有必要在高危人群中预防IE.相比之下,英国国家健康与护理卓越研究所(NICE)建议不要常规使用AP。尽管有相当多的新证据,NICE自2015年以来没有审查过这一建议。在这个个人观点中,我们回顾了自2015年以来出现的新证据。我们的分析建立了国内流离失所者和IE之间的关联,并表明AP既安全又有效地降低了高危人群中国内流离失所者的IE风险。数据还显示,AP具有成本效益,如果重新引入英国的高风险患者国家健康服务,将节省大量成本并带来健康益处。鉴于这些见解,我们认为,现在是NICE审查其指南的时候了,以便英国的高危患者获得与世界其他地区患者相同的针对IE的保护.
    作者没有收到这项工作的具体资助。
    In 2023, the European Society of Cardiology (ESC) updated its infective endocarditis (IE) guidelines strongly endorsing antibiotic prophylaxis (AP) before invasive dental procedures (IDPs) for high-risk patients, elevating their recommendation to Class I. The American Heart Association (AHA) is aligned with this view and reaffirmed the need for AP to prevent IE in those at high-risk in its 2021 guidelines. In contrast, the UK\'s National Institute for Health and Care Excellence (NICE) recommends against routine AP use. Despite considerable new evidence, NICE has not reviewed this recommendation since 2015. In this Personal View, we review the new evidence that has arisen since 2015. Our analysis establishes the association between IDPs and IE and shows that AP is both safe and effective in reducing the IE-risk following IDPs in those at high-risk. Data also show that AP is cost-effective and would result in significant cost savings and health benefits if re-introduced into the UK\'s National Health Service for high-risk patients. Given these insights, we argue it is time NICE reviewed its guidance so that high-risk patients in the UK receive the same protection against IE that is afforded to patients in the rest of the world.
    UNASSIGNED: The authors received no specific funding for this work.
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  • 文章类型: Journal Article
    目的:为了评估NICE的新严重度修改器的影响,它已经取代了报废(EoL)溢价,关于未来的NICE建议,考虑过去的决策模式。
    方法:回顾了2020年1月至2022年12月发表的NICE技术评估(TA)。生成汇总统计数据以评估新的严重程度修饰符如何影响历史TA中的假设决策。
    结果:从132个TA中确定了138个数据点。虽然EoL溢价适用于46次(33%)评估,57(39%)符合基于严重性的QALY乘数。只有19个(14.6%)未获得EoL保费的评估符合严重性标准,多数(17)符合1.2倍乘数的条件。在预测满足严重性标准的评估中,45例(79%)是肿瘤学,与非肿瘤学适应症相比,它们更有资格获得严重程度修正指标的可能性为4.04倍(95%CI:1.91-9.02)。在历史的EoL适应症中,42(91%)预计符合严重程度标准,使他们更有资格获得严重程度修改器的14.8倍(95%CI:6.37-37.6)。
    结论:新的严重程度调节剂将主要受益于肿瘤学适应症,在EoL决策修饰符下继续其先前的明确优先级。然而,Thenewseveritymodifierishardtoachieveandlessgenerous;onlyafractionofassessalsqualifeforthehighesteffective£51,000perQALYthreshold.以前以每QALY50,000英镑的价格批准的绝大多数适应症现在需要满足低于36,000英镑的成本效益门槛。这可能需要制造商提供更大的定价灵活性,并增加负面建议的可能性。
    OBJECTIVE: This study aimed to evaluate the impact of the National Institute for Health and Care Excellence\'s (NICE) new severity modifier, which has replaced the end-of-life (EoL) premium, on future NICE recommendations, considering past decision-making patterns.
    METHODS: NICE technology appraisals (TAs) published between January 2020 and December 2022 were reviewed. Summary statistics were generated to assess how the new severity modifier might affect hypothetical decision making in historical TAs.
    RESULTS: A total of 138 data points were identified from 132 TAs. Although the EoL premium was applied in 46 appraisals (33%), 57 (39%) qualify for a severity-based quality-adjusted life-year (QALY) multiplier. Only 19 appraisals (14.6%) not receiving an EoL premium met the severity criteria, the majority (17) qualifying for a 1.2× multiplier. In appraisals predicted to meet the severity criteria, 45 (79%) were in oncology, making them 4.04 times (95% CI 1.91-9.02) more likely to qualify for a severity modifier than nononcology indications. Among historically EoL indications, 42 (91%) were predicted to meet the severity criteria, making them 14.8 times (95% CI 6.37-37.6) more likely to qualify for a severity modifier.
    CONCLUSIONS: The new severity modifier will predominantly benefit oncology indications, continuing their previous explicit prioritization under the EoL decision modifier. However, the new severity modifier is harder to achieve and less generous; only a fraction of appraisals qualify for the highest effective £51 000 per QALY threshold. The vast majority of indications previously approved at £50 000 per QALY would now need to meet a cost-effectiveness threshold of <£36 000. This may necessitate greater pricing flexibility from manufacturers and increase the likelihood of negative recommendations.
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  • 文章类型: Randomized Controlled Trial
    目的:UKCTOCS为探索临床前浸润性上皮性卵巢癌(iEOC)的症状提供了机会。我们报告了临床前(筛查)癌症(PC)与临床诊断(CD)癌症相比的女性症状。
    方法:在UKCTOCS中,202638绝经后妇女,在2011年12月31日之前,研究人员使用多模式或超声策略,将年龄在50-74岁(2001年4月17日-2005年9月29日)2:1:1随机分配至无筛查或年度筛查.后续行动是通过国家登记册进行的。结果委员会裁定OC诊断,组织型,阶段。符合条件的女性是在初级审查中被诊断为iEOC的女性(2014年12月31日)。从试验临床评估表格和医疗记录中提取症状细节。描述性统计用于比较患有早期(I/II)和晚期(III/IV/无法分期)高级别浆液性(HGSC)癌症的PC和CD女性的症状。ISRCTN-22488978;ClinicalTrials.gov-NCT00058032。
    结果:1133(286PC;847CD)女性发展为iEOC。与CD相比,PC诊断时的中位年龄(岁)更早(66.8PC,68.7CD,p=0.0001)组。在PC组中,48%(112/234;90%,660/730CD)询问时报告了症状。一半PC(50%,13/26PC;36%,29/80CD;p=0.213)有症状的HGSC女性有>1种症状,最常见的腹部症状,两者都在早期(62%,16/26,PC;53%42/80,CD;p=0.421)和高级(57%,49/86,PC;74%,431/580,CD;p=0.001)阶段。在有症状的早期HGSC中,与CD相比,PC女性报告更多的胃肠道(排便习惯和消化不良的改变)(35%,9/26PC;9%,7/80CD;p=0.001)和全身性(主要是嗜睡/疲倦)(27%,7/26PC;9%,7/80CD;p=0.017)症状。
    结论:我们的发现,增加了越来越多的证据,我们应该重新考虑什么是早期卵巢癌的警觉症状。我们需要更细微的关键症状,然后在前瞻性试验中进行评估和完善。
    UKCTOCS provides an opportunity to explore symptoms in preclinical invasive epithelial ovarian cancer (iEOC). We report on symptoms in women with pre-clinical (screen-detected) cancers (PC) compared to clinically diagnosed (CD) cancers.
    In UKCTOCS, 202638 postmenopausal women, aged 50-74 were randomly allocated (April 17, 2001-September 29, 2005) 2:1:1 to no screening or annual screening till Dec 31,2011, using a multimodal or ultrasound strategy. Follow-up was through national registries. An outcomes committee adjudicated on OC diagnosis, histotype, stage. Eligible women were those diagnosed with iEOC at primary censorship (Dec 31, 2014). Symptom details were extracted from trial clinical-assessment forms and medical records. Descriptive statistics were used to compare symptoms in PC versus CD women with early (I/II) and advanced (III/IV/unable to stage) stage high-grade-serous (HGSC) cancer. ISRCTN-22488978; ClinicalTrials.gov-NCT00058032.
    1133 (286PC; 847CD) women developed iEOC. Median age (years) at diagnosis was earlier in PC compared to CD (66.8PC, 68.7CD, p = 0.0001) group. In the PC group, 48% (112/234; 90%, 660/730CD) reported symptoms when questioned. Half PC (50%, 13/26PC; 36%, 29/80CD; p = 0.213) women with symptomatic HGSC had >1symptom, with abdominal symptoms most common, both in early (62%, 16/26, PC; 53% 42/80, CD; p = 0.421) and advanced (57%, 49/86, PC; 74%, 431/580, CD; p = 0.001) stages. In symptomatic early-stage HGSC, compared to CD, PC women reported more gastrointestinal (change in bowel habits and dyspepsia) (35%, 9/26PC; 9%, 7/80CD; p = 0.001) and systemic (mostly lethargy/tiredness) (27%, 7/26PC; 9%, 7/80CD; p = 0.017) symptoms.
    Our findings, add to the growing evidence, that we should reconsider what constitutes alert symptoms for early tubo-ovarian cancer. We need a more nuanced complex of key symptoms which is then evaluated and refined in a prospective trial.
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