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ADNEX risk prediction model for diagnosis of ovarian cancer: systematic review and meta-analysis of external validation studies. 用于诊断卵巢癌的 ADNEX 风险预测模型:外部验证研究的系统回顾和荟萃分析。
Pub Date : 2024-02-17 eCollection Date: 2024-01-01 DOI: 10.1136/bmjmed-2023-000817
Lasai Barreñada, Ashleigh Ledger, Paula Dhiman, Gary Collins, Laure Wynants, Jan Y Verbakel, Dirk Timmerman, Lil Valentin, Ben Van Calster
<p><strong>Objectives: </strong>To conduct a systematic review of studies externally validating the ADNEX (Assessment of Different Neoplasias in the adnexa) model for diagnosis of ovarian cancer and to present a meta-analysis of its performance.</p><p><strong>Design: </strong>Systematic review and meta-analysis of external validation studies.</p><p><strong>Data sources: </strong>Medline, Embase, Web of Science, Scopus, and Europe PMC, from 15 October 2014 to 15 May 2023.</p><p><strong>Eligibility criteria for selecting studies: </strong>All external validation studies of the performance of ADNEX, with any study design and any study population of patients with an adnexal mass. Two independent reviewers extracted the data. Disagreements were resolved by discussion. Reporting quality of the studies was scored with the TRIPOD (Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis) reporting guideline, and methodological conduct and risk of bias with PROBAST (Prediction model Risk Of Bias Assessment Tool). Random effects meta-analysis of the area under the receiver operating characteristic curve (AUC), sensitivity and specificity at the 10% risk of malignancy threshold, and net benefit and relative utility at the 10% risk of malignancy threshold were performed.</p><p><strong>Results: </strong>47 studies (17 007 tumours) were included, with a median study sample size of 261 (range 24-4905). On average, 61% of TRIPOD items were reported. Handling of missing data, justification of sample size, and model calibration were rarely described. 91% of validations were at high risk of bias, mainly because of the unexplained exclusion of incomplete cases, small sample size, or no assessment of calibration. The summary AUC to distinguish benign from malignant tumours in patients who underwent surgery was 0.93 (95% confidence interval 0.92 to 0.94, 95% prediction interval 0.85 to 0.98) for ADNEX with the serum biomarker, cancer antigen 125 (CA125), as a predictor (9202 tumours, 43 centres, 18 countries, and 21 studies) and 0.93 (95% confidence interval 0.91 to 0.94, 95% prediction interval 0.85 to 0.98) for ADNEX without CA125 (6309 tumours, 31 centres, 13 countries, and 12 studies). The estimated probability that the model has use clinically in a new centre was 95% (with CA125) and 91% (without CA125). When restricting analysis to studies with a low risk of bias, summary AUC values were 0.93 (with CA125) and 0.91 (without CA125), and estimated probabilities that the model has use clinically were 89% (with CA125) and 87% (without CA125).</p><p><strong>Conclusions: </strong>The results of the meta-analysis indicated that ADNEX performed well in distinguishing between benign and malignant tumours in populations from different countries and settings, regardless of whether the serum biomarker, CA125, was used as a predictor. A key limitation was that calibration was rarely assessed.</p><p><strong>Systematic review registration:
目的:对用于诊断卵巢癌的 ADNEX(附件不同肿瘤评估)模型的外部验证研究进行系统综述,并对其性能进行荟萃分析:设计:外部验证研究的系统回顾和荟萃分析:数据来源:2014年10月15日至2023年5月15日期间的Medline、Embase、Web of Science、Scopus和Europe PMC:所有关于ADNEX性能的外部验证研究,研究设计不限,研究人群不限,均为附件肿块患者。两名独立审稿人提取数据。有分歧时通过讨论解决。研究的报告质量按照TRIPOD(用于个体预后或诊断的多变量预测模型的透明报告)报告指南进行评分,方法学行为和偏倚风险按照PROBAST(预测模型偏倚风险评估工具)进行评分。对接收者操作特征曲线下面积(AUC)、10%恶性肿瘤风险阈值的敏感性和特异性、10%恶性肿瘤风险阈值的净效益和相对效用进行了随机效应荟萃分析:共纳入 47 项研究(17 007 个肿瘤),研究样本量中位数为 261 个(范围为 24-4905)。平均有 61% 的 TRIPOD 项目得到报告。很少对缺失数据的处理、样本量的合理性以及模型校准进行描述。91%的验证存在高偏倚风险,主要原因是未说明排除不完整病例、样本量小或未对校准进行评估。在接受手术的患者中,区分良性肿瘤和恶性肿瘤的 AUC 总值为 0.93(95% 置信区间为 0.92 至 0.94,95% 预测区间为 0.85 至 0.98)。以血清生物标记物癌症抗原 125 (CA125) 作为预测因子的 ADNEX 预测结果为 0.93(95% 置信区间为 0.92 至 0.94,95% 预测区间为 0.85 至 0.98)(9202 例肿瘤、43 个中心、18 个国家和 21 项研究),而不以 CA125 作为预测因子的 ADNEX 预测结果为 0.93(95% 置信区间为 0.91 至 0.94,95% 预测区间为 0.85 至 0.98)(6309 例肿瘤、31 个中心、13 个国家和 12 项研究)。该模型在新中心临床应用的估计概率为 95%(含 CA125)和 91%(不含 CA125)。将分析范围限制在偏倚风险较低的研究时,AUC 总值分别为 0.93(含 CA125)和 0.91(不含 CA125),模型临床应用的估计概率分别为 89%(含 CA125)和 87%(不含 CA125):荟萃分析的结果表明,无论是否使用血清生物标志物 CA125 作为预测指标,ADNEX 都能很好地区分来自不同国家和环境的人群中的良性肿瘤和恶性肿瘤。一个主要的局限是很少对校准进行评估:系统综述注册:PREMCOCRD42022373182。
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引用次数: 0
Association of vaginal oestradiol and the rate of breast cancer in Denmark: registry based, case-control study, nested in a nationwide cohort. 丹麦阴道雌二醇与乳腺癌发病率的关系:基于登记的病例对照研究,嵌套于全国性队列。
Pub Date : 2024-02-13 eCollection Date: 2024-01-01 DOI: 10.1136/bmjmed-2023-000753
Amani Meaidi, Nelsan Pourhadi, Ellen Christine Løkkegaard, Christian Torp-Pedersen, Lina Steinrud Mørch

Objective: To estimate the rate of breast cancer associated with use of vaginal oestradiol tablets according to duration and intensity of their use.

Design: Registry based, case-control study, nested in a nationwide cohort.

Setting: Based in Denmark using the civil registration system, the national registry of medicinal product statistics, the Danish cancer registry, the Danish birth registry, and statistics Denmark.

Participants: Women aged 50-60 years in year 2000 or turning 50 years during the study period of 1 January 2000 to 31 December 2018 were included. Exclusions were a history of cancer, mastectomy, use of systemic hormone treatment, use of the levonorgestrel releasing intrauterine system, or use of vaginal oestrogen treatments other than oestradiol tablets. To each woman who developed breast cancer during follow-up (18 997), five women in the control group (94 985) were incidence density matched by birth year.

Main outcome measure: The main outcome was pathology confirmed breast cancer diagnosis.

Results: 2782 (14.6%) women with breast cancer (cases) and 14 999 (15.8%) women with no breast cancer diagnosis (controls) had been exposed to vaginal oestradiol tablets with 234 cases and 1232 controls having been in treatment for at least four years at a high intensity (>50 micrograms per week). Increasing durations and intensities of use (cumulative dose/cumulative duration) of vaginal oestradiol tablets was not associated with increasing rates of breast cancer. Compared with never-use, cumulative use of vaginal oestradiol for more than nine years was associated with an adjusted hazard ratio of 0.87 (95% confidence interval 0.69 to 1.11). Results were similar in women who had long term use (≥four years) and with high intensity of use (>50-70 micrograms per week) with an adjusted hazard ratio 0.93 (95% confidence interval 0.81 to 1.08).

Conclusions: Use of vaginal oestradiol tablets was not associated with increased breast cancer rate compared with never-use. Increasing duration and intensity of use was not associated with increased rates of breast cancer.

目的根据阴道雌二醇片的使用时间和强度,估计与使用该药有关的乳腺癌发病率:设计: 基于登记的病例对照研究,嵌套于全国性队列中:研究地点:丹麦,利用民事登记系统、国家医药产品统计登记处、丹麦癌症登记处、丹麦出生登记处和丹麦统计局:研究对象:2000 年 50-60 岁或在 2000 年 1 月 1 日至 2018 年 12 月 31 日研究期间年满 50 岁的女性。癌症病史、乳房切除术、使用全身激素治疗、使用左炔诺孕酮释放宫内系统或使用雌二醇片剂以外的阴道雌激素治疗除外。结果:2782 名(14.6%)患有乳腺癌的妇女(病例)和 14999 名(15.8%)未确诊乳腺癌的妇女(对照组)曾接触过阴道雌二醇片,其中 234 名病例和 1232 名对照组曾接受过至少四年的高强度治疗(每周大于 50 微克)。阴道雌二醇片剂使用时间和强度(累积剂量/累积时间)的增加与乳腺癌发病率的增加无关。与从未使用相比,累计使用阴道雌二醇超过 9 年与调整后的危险比 0.87(95% 置信区间为 0.69 至 1.11)有关。长期使用(≥4年)和高强度使用(每周>50-70微克)的妇女的结果类似,调整后的危险比为0.93(95%置信区间为0.81-1.08):与从不使用相比,使用阴道雌二醇片剂与乳腺癌发病率增加无关。使用时间和强度的增加与乳腺癌发病率的增加无关。
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引用次数: 0
Effect of timeframes to define long term conditions and sociodemographic factors on prevalence of multimorbidity using disease code frequency in primary care electronic health records: retrospective study. 使用初级保健电子健康记录中的疾病代码频率定义长期病症的时限和社会人口因素对多病症患病率的影响:回顾性研究。
Pub Date : 2024-02-13 eCollection Date: 2024-01-01 DOI: 10.1136/bmjmed-2022-000474
Thomas Beaney, Jonathan Clarke, Thomas Woodcock, Azeem Majeed, Mauricio Barahona, Paul Aylin

Objective: To determine the extent to which the choice of timeframe used to define a long term condition affects the prevalence of multimorbidity and whether this varies with sociodemographic factors.

Design: Retrospective study of disease code frequency in primary care electronic health records.

Data sources: Routinely collected, general practice, electronic health record data from the Clinical Practice Research Datalink Aurum were used.

Main outcome measures: Adults (≥18 years) in England who were registered in the database on 1 January 2020 were included. Multimorbidity was defined as the presence of two or more conditions from a set of 212 long term conditions. Multimorbidity prevalence was compared using five definitions. Any disease code recorded in the electronic health records for 212 conditions was used as the reference definition. Additionally, alternative definitions for 41 conditions requiring multiple codes (where a single disease code could indicate an acute condition) or a single code for the remaining 171 conditions were as follows: two codes at least three months apart; two codes at least 12 months apart; three codes within any 12 month period; and any code in the past 12 months. Mixed effects regression was used to calculate the expected change in multimorbidity status and number of long term conditions according to each definition and associations with patient age, gender, ethnic group, and socioeconomic deprivation.

Results: 9 718 573 people were included in the study, of whom 7 183 662 (73.9%) met the definition of multimorbidity where a single code was sufficient to define a long term condition. Variation was substantial in the prevalence according to timeframe used, ranging from 41.4% (n=4 023 023) for three codes in any 12 month period, to 55.2% (n=5 366 285) for two codes at least three months apart. Younger people (eg, 50-75% probability for 18-29 years v 1-10% for ≥80 years), people of some minority ethnic groups (eg, people in the Other ethnic group had higher probability than the South Asian ethnic group), and people living in areas of lower socioeconomic deprivation were more likely to be re-classified as not multimorbid when using definitions requiring multiple codes.

Conclusions: Choice of timeframe to define long term conditions has a substantial effect on the prevalence of multimorbidity in this nationally representative sample. Different timeframes affect prevalence for some people more than others, highlighting the need to consider the impact of bias in the choice of method when defining multimorbidity.

目的确定用于定义长期病症的时间范围对多病症患病率的影响程度,以及这种影响是否随社会人口因素而变化:设计:对初级医疗电子健康记录中的疾病代码频率进行回顾性研究:数据来源:使用从临床实践研究数据链 Aurum 常规收集的全科电子健康记录数据:纳入 2020 年 1 月 1 日在数据库中登记的英格兰成年人(≥18 岁)。多病症的定义是在一组 212 种长期病症中存在两种或两种以上病症。采用五种定义对多病症患病率进行比较。电子病历中记录的 212 种疾病的任何疾病代码都被用作参考定义。此外,对于 41 种需要多个代码的病症(单个疾病代码可表示急性病症)或其余 171 种病症的单个代码,其替代定义如下:相隔至少三个月的两个代码;相隔至少 12 个月的两个代码;任何 12 个月内的三个代码;以及过去 12 个月内的任何代码。混合效应回归法用于计算根据每种定义多病状态和长期病症数量的预期变化,以及与患者年龄、性别、种族群体和社会经济贫困程度的关系:研究共纳入 9 718 573 人,其中 7 183 662 人(73.9%)符合多病状态的定义,即只需一个代码即可定义一种长期病症。根据所使用的时间范围,患病率有很大差异,从在任何 12 个月内有三个代码的 41.4% (n=4 023 023)到相隔至少三个月有两个代码的 55.2% (n=5 366 285)不等。在使用需要多个代码的定义时,年轻人(例如,18-29 岁的概率为 50-75%,而≥80 岁的概率为 1-10%)、某些少数族裔群体(例如,其他族裔群体的概率高于南亚族裔群体)和生活在社会经济贫困地区的人更有可能被重新归类为非多病症:结论:在这一具有全国代表性的样本中,定义长期病症的时间框架的选择对多病症患病率有很大影响。不同的时间框架对某些人的患病率影响更大,这说明在定义多病时需要考虑方法选择偏差的影响。
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引用次数: 0
Published research on the human health implications of climate change between 2012 and 2021: cross sectional study. 2012 年至 2021 年发表的有关气候变化对人类健康影响的研究:横断面研究。
Pub Date : 2024-02-10 eCollection Date: 2024-01-01 DOI: 10.1136/bmjmed-2023-000627
Victoria L Bartlett, Harry Doernberg, Maryam Mooghali, Ravi Gupta, Joshua D Wallach, Kate Nyhan, Kai Chen, Joseph S Ross

Objective: To better understand the state of research on the effects of climate change on human health, including exposures, health conditions, populations, areas of the world studied, funding sources, and publication characteristics, with a focus on topics that are relevant for populations at risk.

Design: Cross sectional study.

Data sources: The National Institute of Environmental Health Sciences climate change and human health literature portal, a curated bibliographical database of global peer reviewed research and grey literature was searched. The database combines searches of multiple search engines including PubMed, Web of Science, and Google Scholar, and includes added-value expert tagging of climate change exposures and health impacts.

Eligibility criteria: Inclusion criteria were peer reviewed, original research articles that investigated the health effects of climate change and were published in English from 2012 to 2021. After identification, a 10% random sample was selected to manually perform a detailed characterisation of research topics and publication information.

Results: 10 325 original research articles were published between 2012 and 2021, and the number of articles increased by 23% annually. In a random sample of 1014 articles, several gaps were found in research topics that are particularly relevant to populations at risk, such as those in the global south (134 countries established through the United Nations Office for South-South Cooperation) (n=444; 43.8%), adults aged 65 years or older (n=195; 19.2%), and on topics related to human conflict and migration (n=25; 2.5%) and food and water quality and security (n=148; 14.6%). Additionally, fewer first authors were from the global south (n=349; 34.4%), which may partly explain why research focusing on these countries is disproportionally less.

Conclusions: Although the body of research on the health effects of climate change has grown substantially over the past decade, including those with a focus on the global south, a disproportionate focus continues to be on countries in the global north and less at risk populations. Governments are the largest source of funding for such research, and governments, particularly in the global north, need to re-orient their climate and health research funding to support researchers in the global south and to be more inclusive of issues that are relevant to the global south.

目标:更好地了解气候变化对人类健康影响的研究状况,包括暴露、健康状况、人群、世界研究地区、资金来源和出版特点,重点关注与高危人群相关的主题:设计:横断面研究:数据来源:对美国国家环境健康科学研究所气候变化与人类健康文献门户网站进行了搜索,该门户网站是一个经过编辑的全球同行评审研究和灰色文献书目数据库。该数据库综合了多个搜索引擎的搜索结果,包括PubMed、Web of Science和Google Scholar,还包括专家对气候变化暴露和健康影响的附加值标记:纳入标准是经同行评审的、调查气候变化对健康影响的原创性研究文章,这些文章在 2012 年至 2021 年期间以英文发表。经过识别后,随机抽取 10%的样本,以人工方式对研究主题和发表信息进行详细描述:结果:2012年至2021年间共发表了10 325篇原创研究文章,文章数量每年增长23%。在随机抽样的1014篇文章中,发现了一些与高危人群特别相关的研究课题存在差距,如全球南部(通过联合国南南合作办公室建立的134个国家)的高危人群(n=444;43.8%)、65岁或以上的成年人(n=195;19.2%),以及与人类冲突和移民(n=25;2.5%)和食品及水质与安全(n=148;14.6%)相关的课题。此外,来自全球南部的第一作者人数较少(n=349;34.4%),这可能部分解释了为什么关注这些国家的研究不成比例地较少:尽管在过去十年中,有关气候变化对健康影响的研究大幅增加,其中包括那些关注全球南部的研究,但不成比例的重点仍然是全球北部国家和风险较低的人群。各国政府是此类研究的最大资金来源,各国政府,特别是全球北方的政府,需要重新调整其气候和健康研究资金的方向,以支持全球南方的研究人员,并更多地考虑与全球南方相关的问题。
{"title":"Published research on the human health implications of climate change between 2012 and 2021: cross sectional study.","authors":"Victoria L Bartlett, Harry Doernberg, Maryam Mooghali, Ravi Gupta, Joshua D Wallach, Kate Nyhan, Kai Chen, Joseph S Ross","doi":"10.1136/bmjmed-2023-000627","DOIUrl":"10.1136/bmjmed-2023-000627","url":null,"abstract":"<p><strong>Objective: </strong>To better understand the state of research on the effects of climate change on human health, including exposures, health conditions, populations, areas of the world studied, funding sources, and publication characteristics, with a focus on topics that are relevant for populations at risk.</p><p><strong>Design: </strong>Cross sectional study.</p><p><strong>Data sources: </strong>The National Institute of Environmental Health Sciences climate change and human health literature portal, a curated bibliographical database of global peer reviewed research and grey literature was searched. The database combines searches of multiple search engines including PubMed, Web of Science, and Google Scholar, and includes added-value expert tagging of climate change exposures and health impacts.</p><p><strong>Eligibility criteria: </strong>Inclusion criteria were peer reviewed, original research articles that investigated the health effects of climate change and were published in English from 2012 to 2021. After identification, a 10% random sample was selected to manually perform a detailed characterisation of research topics and publication information.</p><p><strong>Results: </strong>10 325 original research articles were published between 2012 and 2021, and the number of articles increased by 23% annually. In a random sample of 1014 articles, several gaps were found in research topics that are particularly relevant to populations at risk, such as those in the global south (134 countries established through the United Nations Office for South-South Cooperation) (n=444; 43.8%), adults aged 65 years or older (n=195; 19.2%), and on topics related to human conflict and migration (n=25; 2.5%) and food and water quality and security (n=148; 14.6%). Additionally, fewer first authors were from the global south (n=349; 34.4%), which may partly explain why research focusing on these countries is disproportionally less.</p><p><strong>Conclusions: </strong>Although the body of research on the health effects of climate change has grown substantially over the past decade, including those with a focus on the global south, a disproportionate focus continues to be on countries in the global north and less at risk populations. Governments are the largest source of funding for such research, and governments, particularly in the global north, need to re-orient their climate and health research funding to support researchers in the global south and to be more inclusive of issues that are relevant to the global south.</p>","PeriodicalId":72433,"journal":{"name":"BMJ medicine","volume":"3 1","pages":"e000627"},"PeriodicalIF":0.0,"publicationDate":"2024-02-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10862342/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139731184","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Effect of a prepartum and postpartum, complex interdisciplinary lifestyle and psychosocial intervention on metabolic and mental health outcomes in women with gestational diabetes mellitus (the MySweetheart trial): randomised, single centred, blinded, controlled trial. 产前和产后复杂的跨学科生活方式和社会心理干预对妊娠糖尿病妇女代谢和心理健康结果的影响(MySweetheart 试验):随机、单中心、盲法对照试验。
Pub Date : 2024-02-07 eCollection Date: 2024-01-01 DOI: 10.1136/bmjmed-2023-000588
Dan Yedu Quansah, Leah Gilbert, Amar Arhab, Elena Gonzalez-Rodriguez, Didier Hans, Justine Gross, Stefano Lanzi, Bobby Stuijfzand, Alain Lacroix, Antje Horsch, Jardena J Puder

Objective: To test the effect of a complex, interdisciplinary, lifestyle and psychosocial intervention on metabolic and mental health outcomes in women with gestational diabetes mellitus during pregnancy and in the post partum.

Design: Single centred, single blinded, randomised, controlled trial (the MySweetheart trial).

Setting: Lausanne University Hospital, Switzerland, from 2 September 2016 to 25 October 2021.

Participants: 211 women aged at least 18 years with a diagnosis of gestational diabetes mellitus at 24-32 gestational weeks were randomly assigned (1:1) to the intervention (n=105) or to usual care (n=106).

Interventions: In addition to a comparator based on active guidelines for prepartum and postpartum usual care, the intervention consisted of four individual lifestyle visits during pregnancy and four interdisciplinary visits in the postpartum group, a peer support group workshop in pregnancy and post partum, and a bimonthly lifestyle coach support through telemedicine. The intervention focused on tailored behavioural and psychosocial strategies to improve diet, physical activity, mental health, social support, and adherence to gestational weight gain during pregnancy and weight retention recommendations.

Main outcome measures: Primary outcomes were between-group differences in the decrease in maternal weight and depression symptom scores between baseline and one year post partum. Secondary outcomes included changes in total and central body fat, anxiety, wellbeing, glycaemic parameters (homeostatic model assessment for insulin resistance (known as HOMA-IR) and Matsuda indices), aerobic fitness (maximal oxygen uptake), gestational weight gain, and weight retention. Assessors were blinded to primary and secondary outcomes.

Results: 84 (80%) of 105 women in the intervention and 95 (90%) of 106 in the usual care completed the study. There was not enough evidence of a difference in the decrease in weight (mean difference -0.38 kg (95% confidence interval -2.08 to 1.30)) or depression scores (-0.67 (-1.84 to 0.49)). The intervention led to an increase in fat-free mass (0.02 kg (0.01 to 0.03)). The intervention also decreased gestational weight gain since the first gestational diabetes mellitus visit (-1.20 kg (-2.14 to -0.26)) and weekly weight gain throughout the entire pregnancy (-0.14 kg (-0.25 to -0.03)), and led to a higher proportion of women without weight retention at one year post partum (34.1% (28/82) v 20.8% (20/96), P=0.034).

Conclusions: Compared with active usual care based on guidelines, there was not enough evidence to conclude that the intervention led to decrease in weight or depression symptoms. However, the intervention decreased gestational weight gain and increased the proportion of women without weight retention.

Trial

目的检验一种复杂的、跨学科的生活方式和社会心理干预对妊娠期和产后妊娠糖尿病妇女的代谢和心理健康结果的影响:设计:单中心、单盲、随机对照试验(MySweetheart 试验):参与者:211名年龄在18周岁以上、妊娠周数在24-32周、确诊患有妊娠糖尿病的女性被随机分配(1:1)至干预方案(105人)或常规护理方案(106人):干预措施:除了基于产前和产后常规护理积极指南的比较对象外,干预措施还包括孕期的四次个人生活方式访视和产后组的四次跨学科访视、孕期和产后的同伴支持小组研讨会,以及通过远程医疗提供的每两个月一次的生活方式指导支持。干预措施侧重于量身定制的行为和社会心理策略,以改善饮食、体育锻炼、心理健康、社会支持,以及遵守孕期体重增加和体重保持建议:主要结果是基线和产后一年之间产妇体重和抑郁症状评分下降的组间差异。次要结果包括总脂肪和中心体脂、焦虑、幸福感、血糖参数(胰岛素抵抗静态模型评估(HOMA-IR)和松田指数)、有氧健身(最大摄氧量)、妊娠体重增加和体重保持的变化。评估人员对主要和次要结果进行了盲测:105名接受干预的妇女中有84人(80%)完成了研究,106名接受常规护理的妇女中有95人(90%)完成了研究。没有足够的证据表明体重下降(平均差异为-0.38千克(95%置信区间为-2.08至1.30))或抑郁评分(-0.67(-1.84至0.49))有差异。干预措施使无脂质量增加(0.02 千克(0.01 至 0.03))。干预还降低了自首次妊娠糖尿病就诊以来的妊娠体重增加(-1.20千克(-2.14至-0.26))和整个孕期每周体重增加(-0.14千克(-0.25至-0.03)),并提高了产后一年体重无变化的妇女比例(34.1%(28/82)v 20.8%(20/96),P=0.034):与基于指南的积极常规护理相比,没有足够的证据可以得出结论说干预措施导致了体重或抑郁症状的减轻。然而,干预措施降低了妊娠体重的增加,并提高了无体重潴留妇女的比例:试验注册:Clinicaltrials.gov NCT02890693。
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引用次数: 0
Design differences and variation in results between randomised trials and non-randomised emulations: meta-analysis of RCT-DUPLICATE data. 随机试验与非随机模拟之间的设计差异和结果差异:RCT-DUPLICATE 数据的荟萃分析。
Pub Date : 2024-02-05 eCollection Date: 2024-01-01 DOI: 10.1136/bmjmed-2023-000709
Rachel Heyard, Leonhard Held, Sebastian Schneeweiss, Shirley V Wang

Objective: To explore how design emulation and population differences relate to variation in results between randomised controlled trials (RCT) and non-randomised real world evidence (RWE) studies, based on the RCT-DUPLICATE initiative (Randomised, Controlled Trials Duplicated Using Prospective Longitudinal Insurance Claims: Applying Techniques of Epidemiology).

Design: Meta-analysis of RCT-DUPLICATE data.

Data sources: Trials included in RCT-DUPLICATE, a demonstration project that emulated 32 randomised controlled trials using three real world data sources: Optum Clinformatics Data Mart, 2004-19; IBM MarketScan, 2003-17; and subsets of Medicare parts A, B, and D, 2009-17.

Eligibility criteria for selecting studies: Trials where the primary analysis resulted in a hazard ratio; 29 RCT-RWE study pairs from RCT-DUPLICATE.

Results: Differences and variation in effect sizes between the results from randomised controlled trials and real world evidence studies were investigated. Most of the heterogeneity in effect estimates between the RCT-RWE study pairs in this sample could be explained by three emulation differences in the meta-regression model: treatment started in hospital (which does not appear in health insurance claims data), discontinuation of some baseline treatments at randomisation (which would have been an unusual care decision in clinical practice), and delayed onset of drug effects (which would be under-reported in real world clinical practice because of the relatively short persistence of the treatment). Adding the three emulation differences to the meta-regression reduced heterogeneity from 1.9 to almost 1 (absence of heterogeneity).

Conclusions: This analysis suggests that a substantial proportion of the observed variation between results from randomised controlled trials and real world evidence studies can be attributed to differences in design emulation.

目的以 RCT-DUPLICATE 计划(利用前瞻性纵向保险索赔重复进行的随机对照试验)为基础,探讨设计仿真和人群差异与随机对照试验 (RCT) 和非随机真实世界证据 (RWE) 研究结果差异之间的关系:设计:设计:对 RCT-DUPLICATE 数据进行元分析:RCT-DUPLICATE是一个示范项目,利用三个真实世界的数据源模拟了32项随机对照试验:Optum Clinformatics Data Mart,2004-19 年;IBM MarketScan,2003-17 年;Medicare A、B 和 D 部分子集,2009-17 年:主要分析结果为危险比的试验;来自 RCT-DUPLICATE 的 29 个 RCT-RWE 研究对:结果:调查了随机对照试验和真实世界证据研究结果之间效应大小的差异和变化。在该样本中,RCT-RWE 研究对之间效应估计值的大部分异质性可通过元回归模型中的三个仿真差异来解释:在医院开始治疗(这并不出现在医疗保险理赔数据中)、在随机化时中止某些基线治疗(这在临床实践中将是一个不寻常的护理决策)以及药物效应的延迟开始(由于治疗的持续时间相对较短,这在真实世界的临床实践中将被低估)。在元回归中加入这三种仿真差异后,异质性从 1.9 降至接近 1(无异质性):这项分析表明,在随机对照试验和实际证据研究的结果之间观察到的差异中,有很大一部分可归因于设计仿真的差异。
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引用次数: 0
Post-covid-19 conditions in adults: systematic review and meta-analysis of health outcomes in controlled studies. 成人 19 岁后的情况:对照研究中健康结果的系统回顾和荟萃分析。
Pub Date : 2024-01-29 eCollection Date: 2024-01-01 DOI: 10.1136/bmjmed-2023-000723
Juan Victor Ariel Franco, Luis Ignacio Garegnani, Maria-Inti Metzendorf, Katharina Heldt, Rebekka Mumm, Christa Scheidt-Nave
<p><strong>Objective: </strong>To assess the impact of post-covid-19 conditions among adults.</p><p><strong>Design: </strong>Systematic review and meta-analysis of health outcomes in controlled studies.</p><p><strong>Data sources: </strong>Two sources were searched from database inception to 20 October 2022: Cochrane covid-19 study register (comprising Cochrane Central Register of Controlled Trials, Medline, Embase, clinicalTrials.gov, World Health Organization's International Clinical Trials Registry Platform, medRxiv) and WHO's covid-19 research database.</p><p><strong>Eligibility criteria: </strong>Cohort studies recruiting more than 100 participants with a control group and a follow-up of at least 12 weeks were included. Adults who were documented to have SARS-CoV-2 infection based on clinical, imaging, or laboratory criteria were included.</p><p><strong>Data extraction and synthesis: </strong>Two independent reviewers extracted data. The main outcomes included quality of life, functionality in daily activities, use of resources, recovery rates (cluster of symptoms), and the incidence of new medical diagnoses. Data were pooled using a random effects model. The risk of bias was assessed with the Joanna Briggs Institute critical appraisal tool for cohort studies.</p><p><strong>Results: </strong>We included 63 controlled cohort studies, encompassing more than 96 million participants. Based on five studies, we found a reduction in overall quality of life between individuals with confirmed SARS-CoV-2 infection versus controls at six to 24 months follow-up, although heterogeneity was very high (mean difference in EQ-5D scale -5.28 (95% confidence interval -7.88 to 2.68; I<sup>2</sup>=93.81%). Evidence from ten studies, which could not be pooled in a meta-analysis, indicated that an increased rate of functional impairment associated with SARS-CoV-2 infection. Use of care increased compared with controls at six to 24 months follow-up at intensive care units (risk ratio 2.00 (95% confidence interval 0.69 to 5.80), five studies, I<sup>2</sup>=91.96%) and in outpatient care (1.12 (1.01 to 1.24), seven studies, I<sup>2</sup>=99.51%). Regarding persistent symptoms, individuals with documented SARS-CoV-2 infection had an increased risk of having two or more persistent symptoms at follow-up, especially those related to neurological clusters (ie, risk ratio 1.51 (95% confidence interval 1.17 to 1.93), I<sup>2</sup>=98.91%). Evidence also showed an increased incidence of a wide variety of metabolic, cardiovascular, neurological, respiratory, haematological and other incident diagnoses.</p><p><strong>Conclusion: </strong>Evidence suggests functional impairment after SARS-CoV-2 infection, in addition to a higher use of resources and a higher incidence of widely varying medical diagnoses. These results should be interpreted with caution, considering the high heterogeneity across studies and study limitations related to outcome measurement and attrition of partic
目标评估 19 岁以上成年人受艾滋病毒感染后情况的影响:数据来源:对对照研究中的健康结果进行系统回顾和荟萃分析:从数据库建立之初到2022年10月20日,我们检索了两个数据源:Cochrane covid-19研究登记簿(包括Cochrane对照试验中央登记簿、Medline、Embase、clinicalTrials.gov、世界卫生组织国际临床试验登记平台、medRxiv)和世界卫生组织covid-19研究数据库:纳入的队列研究需招募 100 名以上参与者,并设有对照组和至少 12 周的随访。根据临床、影像学或实验室标准被证实感染了SARS-CoV-2的成人也被纳入研究范围:两名独立审稿人提取了数据。主要结果包括生活质量、日常活动功能、资源使用、康复率(症状群)和新医疗诊断的发生率。数据采用随机效应模型进行汇总。采用乔安娜-布里格斯研究所的队列研究关键评估工具对偏倚风险进行了评估:我们纳入了 63 项对照队列研究,参与者超过 9600 万人。基于五项研究,我们发现在六到二十四个月的随访中,确诊 SARS-CoV-2 感染者与对照组相比,总体生活质量有所下降,但异质性非常高(EQ-5D 量表的平均差异为-5.28(95% 置信区间为-7.88 至 2.68;I2=93.81%)。来自十项研究的证据表明,SARS-CoV-2 感染导致的功能损伤率增加。与对照组相比,在重症监护室(风险比为 2.00(95% 置信区间为 0.69 至 5.80),5 项研究,I2=91.96%)和门诊(1.12(1.01 至 1.24),7 项研究,I2=99.51%)随访 6 至 24 个月时使用护理的情况有所增加。关于持续性症状,有记录的 SARS-CoV-2 感染者在随访时出现两种或两种以上持续性症状的风险增加,尤其是与神经系统相关的症状(即风险比 1.51(95% 置信区间 1.17 至 1.93),I2=98.91%)。证据还显示,各种代谢、心血管、神经、呼吸、血液和其他事件诊断的发生率也有所增加:结论:有证据表明,感染 SARS-CoV-2 后,除了资源使用率较高和各种医疗诊断的发生率较高之外,功能也会受到损害。考虑到各项研究之间的高度异质性以及与结果测量和参与者自然减员有关的研究局限性,在解释这些结果时应谨慎:系统综述注册:开放科学框架,osf.io/drm39。
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引用次数: 0
Covid-19 pandemic and equity of global human papillomavirus vaccination: descriptive study of World Health Organization-Unicef vaccination coverage estimates. Covid-19 大流行与全球人类乳头瘤病毒疫苗接种的公平性:对世界卫生组织-联合国儿童基金会疫苗接种覆盖率估计值的描述性研究。
Pub Date : 2024-01-29 eCollection Date: 2024-01-01 DOI: 10.1136/bmjmed-2023-000726
Rebecca Mary Casey, Hiroki Akaba, Terri B Hyde, Paul Bloem
<p><strong>Objective: </strong>To analyse progress in global vaccination against human papillomavirus (HPV) during the covid-19 pandemic, with a particular focus on equity.</p><p><strong>Design: </strong>Descriptive study of World Health Organization-Unicef vaccination coverage estimates.</p><p><strong>Setting: </strong>WHO-Unicef estimates of global, regional, and national HPV vaccination coverage, before (2010-19) and during (2020-21) the covid-19 pandemic.</p><p><strong>Participants: </strong>Girls aged 9-14 years who received a HPV vaccine globally before (12.3 million in 2019) and during (2020-21) the covid-19 pandemic (10.6 million in 2021).</p><p><strong>Main outcome measures: </strong>Mean programme and population adjusted coverage for first dose HPV vaccine (HPV1) by country, country income (World Bank income categories), sex, and WHO region, before (2010-19) and during (2020-21) the covid-19 pandemic, based on WHO-Unicef estimates of HPV vaccination coverage. Annual number of national HPV vaccine programme introduced since the first HPV vaccine licence was granted in 2006, based on data reported to WHO-Unicef. Number of girls vaccinated before (2019) versus during (2020-21) the covid-19 pandemic period.</p><p><strong>Results: </strong>Mean coverage of HPV vaccination programmes among girls decreased from 65% in 2010-19 to 50% in 2020-21 in low and middle income countries compared with an increase in high income countries from 61% to 69% for the same periods. Population adjusted HPV1 coverage was higher among girls in high income countries before and during the covid-19 pandemic than in girls in low and middle income countries. During the covid-19 pandemic, population adjusted HPV1 coverage among boys in high income countries was higher and remained higher than coverage among girls in low and middle income countries. Globally, 23 countries recorded a severe reduction in their HPV programme (≥50% reduction in coverage), and another 3.8 million girls globally did not receive a HPV vaccine in countries with existing HPV vaccination programmes in 2020-21 compared with 2019. A reduction was seen in the annual rate of new introductions of national HPV vaccine programmes during 2020-21, affecting countries in all income categories, followed by an increase in introductions during 2022. During the second half of 2023, several low and middle income countries with large birth cohorts and a high relative burden of cervical cancer have yet to introduce HPV vaccination.</p><p><strong>Conclusions: </strong>Although HPV vaccines have been available for more than 15 years, global HPV vaccination coverage is low. During the covid-19 pandemic period (2020-21 globally), worsening coverage, delayed introductions of national vaccine programmes, and an increase in missed girls globally (ie, girls who did not receive a HPV vaccine compared with the previous year in countries with an existing HPV vaccination programme) that disproportionately affected girls in l
目的分析在covid-19大流行期间全球人类乳头瘤病毒(HPV)疫苗接种的进展情况,尤其关注公平性:设计:对世界卫生组织-联合国儿童基金会疫苗接种覆盖率估计值进行描述性研究:世界卫生组织-联合国儿童基金会对covid-19大流行之前(2010-19年)和期间(2020-21年)全球、地区和国家HPV疫苗接种覆盖率的估计:主要结果指标:根据世卫组织-联合国艾滋病规划署(WHO-Unicef)对HPV疫苗接种覆盖率的估计,在covid-19大流行之前(2010-19年)和期间(2020-21年),按国家、国家收入(世界银行收入类别)、性别和世卫组织地区划分的第一剂HPV疫苗(HPV1)计划和人口调整后的平均覆盖率。根据向世界卫生组织-联合国儿童基金会报告的数据,自 2006 年获得首个 HPV 疫苗许可证以来,每年实施的国家 HPV 疫苗计划数量。在covid-19大流行之前(2019年)和期间(2020-21年)接种疫苗的女孩人数:在中低收入国家,女童接种HPV疫苗计划的平均覆盖率从2010-19年的65%降至2020-21年的50%,而同期高收入国家的覆盖率从61%增至69%。在covid-19大流行之前和期间,高收入国家女童的人口调整后HPV1覆盖率高于中低收入国家。在covid-19大流行期间,高收入国家男孩的人口调整后HPV1覆盖率高于中低收入国家女孩的覆盖率,而且一直保持在较高水平。与2019年相比,全球有23个国家的HPV疫苗接种计划严重缩减(覆盖率减少≥50%),2020-21年,在已有HPV疫苗接种计划的国家中,全球还有380万女童没有接种HPV疫苗。在 2020-21 年期间,国家 HPV 疫苗接种计划的年新增接种率有所下降,影响到所有收入类别的国家,随后在 2022 年期间新增接种率有所上升。2023 年下半年,一些出生人口众多、宫颈癌相对负担较重的中低收入国家尚未引入 HPV 疫苗接种:结论:尽管 HPV 疫苗问世已超过 15 年,但全球 HPV 疫苗接种覆盖率仍然很低。在covid-19大流行期间(2020-21年全球范围内),发现覆盖率不断下降、国家疫苗计划引入延迟,以及全球漏种女童人数增加(即在已有HPV疫苗接种计划的国家,与前一年相比,未接种HPV疫苗的女童人数增加),中低收入国家的女童受到的影响尤为严重。需要采取紧急和创新的恢复措施,以加快各国引入 HPV 疫苗接种计划的速度,并在全球范围内实现 HPV 疫苗接种的高覆盖率。
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引用次数: 0
Availability of results of clinical trials registered on EU Clinical Trials Register: cross sectional audit study. 欧盟临床试验登记册上登记的临床试验结果的可用性:横断面审计研究。
Pub Date : 2024-01-12 eCollection Date: 2024-01-01 DOI: 10.1136/bmjmed-2023-000738
Nicholas J DeVito, Jessica Morley, James Andrew Smith, Henry Drysdale, Ben Goldacre, Carl Heneghan

Objective: To identify the availability of results for trials registered on the European Union Clinical Trials Register (EUCTR) compared with other dissemination routes to understand its value as a results repository.

Design: Cross sectional audit study.

Setting: EUCTR protocols and results sections, data extracted 1-3 December 2020.

Population: Random sample of 500 trials registered on EUCTR with a completion date of more than two years from the beginning of searches (ie, 1 December 2018).

Main outcome measures: Proportion of trials with results across the examined dissemination routes (EUCTR, ClinicalTrials.gov, ISRCTN registry, and journal publications), and for each dissemination route individually. Prespecified secondary outcomes were number and proportion of unique results, and the timing of results, for each dissemination route.

Results: In the sample of 500 trials, availability of results on EUCTR (53.2%, 95% confidence interval 48.8% to 57.6%) was similar to the peer reviewed literature (58.6%, 54.3% to 62.9%) and exceeded the proportion of results available on other registries with matched records. Among the 383 trials with any results, 55 (14.4%, 10.9% to 17.9%) were only available on EUCTR. Also, after the launch of the EUCTR results database, median time to results was fastest on EUCTR (1142 days, 95% confidence interval 812 to 1492), comparable with journal publications (1226 days, 1074 to 1551), and exceeding ClinicalTrials.gov (3321 days, 1653 to undefined). For 117 trials (23.4%, 19.7% to 27.1%), however, results were published elsewhere but not submitted to the EUCTR registry, and no results were located in any dissemination route for 117 trials (23.4%, 19.7% to 27.1).

Conclusions: EUCTR should be considered in results searches for systematic reviews and can help researchers and the public to access the results of clinical trials, unavailable elsewhere, in a timely way. Reporting requirements, such as the EU's, can help in avoiding research waste by ensuring results are reported. The registry's true value, however, is unrealised because of inadequate compliance with EU guidelines, and problems with data quality that complicate the routine use of the registry. As the EU transitions to a new registry, continuing to emphasise the importance of EUCTR and the provision of timely and complete data is critical. For the future, EUCTR will still hold important information from the past two decades of clinical research in Europe. With increased efforts from sponsors and regulators, the registry can continue to grow as a source of results of clinical trials, many of which might be unavailable from other dissemination routes.

目的与其他传播途径相比,确定在欧盟临床试验注册中心(EUCTR)注册的试验结果的可用性,以了解其作为结果库的价值:设计:横断面审计研究:环境:EUCTR协议和结果部分,2020年12月1日至3日提取的数据:在EUCTR上注册的500项试验的随机样本,试验完成日期距检索开始日期超过两年(即2018年12月1日):在已审查的传播途径(EUCTR、ClinicalTrials.gov、ISRCTN 注册表和期刊出版物)中有结果的试验比例,以及每种传播途径的单独比例。预设的次要结果是每种传播途径的唯一结果的数量和比例,以及结果的时间:在500项试验样本中,EUCTR(53.2%,95%置信区间为48.8%至57.6%)提供的结果与同行评议文献(58.6%,54.3%至62.9%)相似,并且超过了其他具有匹配记录的登记处提供的结果比例。在有任何结果的 383 项试验中,有 55 项(14.4%,10.9% 至 17.9%)仅在 EUCTR 中提供。此外,EUCTR结果数据库推出后,在EUCTR上获得结果的中位时间最快(1142天,95%置信区间为812-1492),与期刊发表的时间(1226天,1074-1551)相当,超过了ClinicalTrials.gov(3321天,1653-未定义)。然而,有117项试验(23.4%,19.7%至27.1%)的结果在其他地方发表,但没有提交给EUCTR登记处,有117项试验(23.4%,19.7%至27.1%)的结果没有在任何传播途径中找到:结论:在系统性综述的结果搜索中应考虑到EUCTR,它可以帮助研究人员和公众及时获取其他地方没有的临床试验结果。报告要求(如欧盟的报告要求)可确保结果得到报告,从而有助于避免研究浪费。然而,由于没有充分遵守欧盟的指导方针,以及数据质量问题使注册表的日常使用复杂化,注册表的真正价值并未实现。随着欧盟向新的登记处过渡,继续强调 EUCTR 的重要性以及提供及时、完整的数据至关重要。未来,EUCTR 仍将保存欧洲过去二十年临床研究的重要信息。随着申办者和监管者的进一步努力,该登记处将继续发展成为临床试验结果的来源,其中许多结果可能无法通过其他途径传播。
{"title":"Availability of results of clinical trials registered on EU Clinical Trials Register: cross sectional audit study.","authors":"Nicholas J DeVito, Jessica Morley, James Andrew Smith, Henry Drysdale, Ben Goldacre, Carl Heneghan","doi":"10.1136/bmjmed-2023-000738","DOIUrl":"10.1136/bmjmed-2023-000738","url":null,"abstract":"<p><strong>Objective: </strong>To identify the availability of results for trials registered on the European Union Clinical Trials Register (EUCTR) compared with other dissemination routes to understand its value as a results repository.</p><p><strong>Design: </strong>Cross sectional audit study.</p><p><strong>Setting: </strong>EUCTR protocols and results sections, data extracted 1-3 December 2020.</p><p><strong>Population: </strong>Random sample of 500 trials registered on EUCTR with a completion date of more than two years from the beginning of searches (ie, 1 December 2018).</p><p><strong>Main outcome measures: </strong>Proportion of trials with results across the examined dissemination routes (EUCTR, ClinicalTrials.gov, ISRCTN registry, and journal publications), and for each dissemination route individually. Prespecified secondary outcomes were number and proportion of unique results, and the timing of results, for each dissemination route.</p><p><strong>Results: </strong>In the sample of 500 trials, availability of results on EUCTR (53.2%, 95% confidence interval 48.8% to 57.6%) was similar to the peer reviewed literature (58.6%, 54.3% to 62.9%) and exceeded the proportion of results available on other registries with matched records. Among the 383 trials with any results, 55 (14.4%, 10.9% to 17.9%) were only available on EUCTR. Also, after the launch of the EUCTR results database, median time to results was fastest on EUCTR (1142 days, 95% confidence interval 812 to 1492), comparable with journal publications (1226 days, 1074 to 1551), and exceeding ClinicalTrials.gov (3321 days, 1653 to undefined). For 117 trials (23.4%, 19.7% to 27.1%), however, results were published elsewhere but not submitted to the EUCTR registry, and no results were located in any dissemination route for 117 trials (23.4%, 19.7% to 27.1).</p><p><strong>Conclusions: </strong>EUCTR should be considered in results searches for systematic reviews and can help researchers and the public to access the results of clinical trials, unavailable elsewhere, in a timely way. Reporting requirements, such as the EU's, can help in avoiding research waste by ensuring results are reported. The registry's true value, however, is unrealised because of inadequate compliance with EU guidelines, and problems with data quality that complicate the routine use of the registry. As the EU transitions to a new registry, continuing to emphasise the importance of EUCTR and the provision of timely and complete data is critical. For the future, EUCTR will still hold important information from the past two decades of clinical research in Europe. With increased efforts from sponsors and regulators, the registry can continue to grow as a source of results of clinical trials, many of which might be unavailable from other dissemination routes.</p>","PeriodicalId":72433,"journal":{"name":"BMJ medicine","volume":"3 1","pages":"e000738"},"PeriodicalIF":0.0,"publicationDate":"2024-01-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10806997/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139565387","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Transgender identity in young people and adults recorded in UK primary care electronic patient records: retrospective, dynamic, cohort study. 英国初级保健电子病历中记录的年轻人和成年人的跨性别认同:回顾性、动态、队列研究
Pub Date : 2023-11-28 eCollection Date: 2023-01-01 DOI: 10.1136/bmjmed-2023-000499
Douglas Gordon John McKechnie, Elizabeth O'Nions, Julia Bailey, Lorna Hobbs, Frank Gillespie, Irene Petersen

Objectives: To quantify the change in proportion of young people and adults identified as transgender in UK primary care records and to explore whether rates differ by age and socioeconomic deprivation.

Design: Retrospective, dynamic, cohort study.

Setting: IQVIA Medical Research Data, a database of electronic primary care records capturing data from 649 primary care practices in the UK between 1 January 2000 and 31 December 2018.

Participants: 7 064 829 individuals aged 10-99 years, in all four UK countries.

Main outcome measures: Diagnostic codes indicative of transgender identity were used. Sex assigned at birth was estimated by use of masculinising or feminising medication and procedural/diagnostic codes.

Results: 2462 (0.03%) individuals had a record code indicating a transgender identity. Direction of transition could be estimated for 1340 (54%) people, of which 923 were assigned male at birth, and 417 were assigned female at birth. Rates of recording in age groups diverged substantially after 2010. Rates of the first recording of codes were highest in ages 16-17 years (between 2010 and 2018: 24.51/100 000 person years (95% confidence interval 20.95 to 28.50)). Transgender codes were associated with deprivation: the rate of the first recording was 1.59 (95% confidence interval 1.31 to 1.92) in the most deprived group in comparison with the least deprived group. Additionally, the rate ratio of the proportion of people who identified as transgender was 2.45 (95% confidence interval 2.28 to 2.65) in the most deprived group compared with the least deprived group. Substantial increases were noted in newly recorded transgender codes over time in all age groups (1.45/100 000 person years in 2000 (95% confidence interval 0.96 to 2.10) to 7.81/100 000 person years in 2018 (6.57 to 9.22)). In 2018, the proportion of people with transgender identity codes was highest in the age groups 16-17 years (16.23 per 10 000 (95% confidence interval 12.60 to 20.57)) and 18-29 years (12.42 per 10 000 (11.06 to 13.90)).

Conclusion: The rate of transgender identity recorded in primary care records has increased fivefold from 2000 to 2018 and is highest in the 16-17 and 18-29 age groups. Transgender diagnostic coding is associated with socioeconomic deprivation and further work should investigate this association. Primary and specialist care should be commissioned accordingly to provide for the gender specific and general health needs of transgender people.

目的:量化英国初级保健记录中被认定为跨性别者的年轻人和成年人比例的变化,并探讨这一比例是否因年龄和社会经济剥夺而不同。设计:回顾性、动态、队列研究。设置:IQVIA医学研究数据,这是一个电子初级保健记录数据库,收集了2000年1月1日至2018年12月31日期间英国649个初级保健实践的数据。参与者:7 064 829人年龄10-99岁,在所有四个英国国家。主要结果测量:使用指示跨性别身份的诊断代码。通过使用男性化或女性化的药物和程序/诊断代码来估计出生时的性别。结果:2462人(0.03%)有跨性别身份的记录代码。1340人(54%)可估计性别转换方向,其中923人出生时为男性,417人出生时为女性。2010年之后,各年龄组的记录率存在显著差异。首次记录代码的比率在16-17岁年龄段最高(2010年至2018年:24.51/10万人年(95%置信区间为20.95至28.50))。跨性别代码与贫困有关:与最贫困组相比,最贫困组的第一次记录率为1.59(95%可信区间为1.31至1.92)。此外,最贫困群体与最贫困群体的跨性别者比例之比为2.45(95%可信区间2.28 ~ 2.65)。随着时间的推移,所有年龄组新记录的跨性别代码都大幅增加(2000年为1.45/10万人年(95%置信区间0.96至2.10),2018年为7.81/10万人年(6.57至9.22))。2018年,16-17岁(16.23 / 10000(95%置信区间12.60 - 20.57))和18-29岁(12.42 / 10000(11.06 - 13.90))年龄组拥有跨性别身份代码的人口比例最高。结论:从2000年到2018年,初级保健记录中记录的跨性别认同率增加了5倍,其中16-17岁和18-29岁年龄组的比例最高。跨性别诊断编码与社会经济剥夺有关,应该进一步研究这种联系。应相应地委托提供初级和专科护理,以满足跨性别者的特定性别和一般保健需求。
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引用次数: 0
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BMJ medicine
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