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Transparent reporting of adaptive clinical trials using concurrently randomised cohorts. 使用同时随机队列的适应性临床试验的透明报告。
Pub Date : 2023-09-19 eCollection Date: 2023-01-01 DOI: 10.1136/bmjmed-2023-000497
Ian C Marschner, Mark Jones, James A Totterdell, Robert K Mahar, Thomas L Snelling, Steven Y C Tong

Adaptive clinical trials have designs that evolve over time because of changes to treatments or changes to the chance that participants will receive these treatments. These changes might introduce confounding that biases crude comparisons of the treatment arms and makes the results from standard reporting methods difficult to interpret for adaptive trials. To deal with this shortcoming, a reporting framework for adaptive trials was developed based on concurrently randomised cohort reporting. A concurrently randomised cohort is a subgroup of participants who all had the same treatments available and the same chance of receiving these treatments. The reporting of pre-randomisation characteristics and post-randomisation outcomes for each concurrently randomised cohort in the study is recommended. This approach provides a transparent and unbiased display of the degree of baseline balance and the randomised treatment comparisons for adaptive trials. The key concepts, terminology, and recommendations underlying concurrently randomised cohort reporting are presented, and its routine use in adaptive trial reporting is advocated.

适应性临床试验的设计会随着时间的推移而变化,因为治疗方法的变化或参与者接受这些治疗的机会的变化。这些变化可能会引入混淆,使治疗组的粗略比较产生偏差,并使标准报告方法的结果难以解释为适应性试验。为了解决这一缺陷,在同时进行随机队列报告的基础上,开发了一个适应性试验的报告框架。同时随机队列是一组参与者,他们都有相同的治疗方法,接受这些治疗的机会也相同。建议报告研究中每个同时随机化的队列的随机化前特征和随机化后结果。这种方法为适应性试验的基线平衡程度和随机治疗比较提供了透明和无偏见的显示。介绍了并发随机队列报告的关键概念、术语和建议,并提倡其在适应性试验报告中的常规使用。
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引用次数: 0
Preconception contraceptive use and miscarriage: prospective cohort study. 孕前避孕药具的使用与流产:前瞻性队列研究。
Pub Date : 2023-09-11 eCollection Date: 2023-01-01 DOI: 10.1136/bmjmed-2023-000569
Jennifer J Yland, Amelia K Wesselink, Sonia Hernandez-Diaz, Krista Huybrechts, Elizabeth E Hatch, Tanran R Wang, David Savitz, Wendy Kuohung, Kenneth J Rothman, Lauren A Wise

Objectives: To evaluate the association between preconception contraceptive use and miscarriage.

Design: Prospective cohort study.

Setting: Residents of the United States of America or Canada, recruited from 2013 until the end of 2022.

Participants: 13 460 female identified participants aged 21-45 years who were planning a pregnancy were included, of whom 8899 conceived. Participants reported data for contraceptive history, early pregnancy, miscarriage, and potential confounders during preconception and pregnancy.

Main outcome measure: Miscarriage, defined as pregnancy loss before 20 weeks of gestation.

Results: Preconception use of combined and progestin-only oral contraceptives, hormonal intrauterine devices, copper intrauterine devices, rings, implants, or natural methods was not associated with miscarriage compared with use of barrier methods. Participants who most recently used patch (incidence rate ratios 1.34 (95% confidence interval 0.81 to 2.21)) or injectable contraceptives (1.44 (0.99 to 2.12)) had higher rates of miscarriage compared with recent users of barrier methods, although results were imprecise due to the small numbers of participants who used patch and injectable contraceptives.

Conclusions: Use of most contraceptives before conception was not appreciably associated with miscarriage rate. Individuals who used patch and injectable contraceptives had higher rates of miscarriage relative to users of barrier methods, although these results were imprecise and residual confounding was possible.

目的: 评估孕前避孕与流产之间的关系:评估孕前避孕药具的使用与流产之间的关系:设计:前瞻性队列研究:参与者:13 460 名年龄在 21-45 岁之间、计划怀孕的女性:共纳入 13 460 名年龄在 21-45 岁之间、计划怀孕的女性参与者,其中 8899 人受孕。参与者报告了避孕史、早孕、流产以及孕前和孕期潜在混杂因素的数据。主要结果指标:流产,定义为妊娠 20 周前的妊娠损失:结果:与使用屏障避孕法相比,孕前使用复方和纯孕激素口服避孕药、激素宫内节育器、铜宫内节育器、避孕环、皮下埋植剂或自然避孕法与流产无关。最近使用贴片避孕药(发生率比为1.34(95%置信区间为0.81-2.21))或注射避孕药(1.44(0.99-2.12))的受试者与最近使用屏障避孕法的受试者相比,流产率较高,但由于使用贴片避孕药和注射避孕药的受试者人数较少,结果并不精确:结论:受孕前使用大多数避孕药与流产率并无明显关系。使用贴片避孕药和注射避孕药的人的流产率高于使用屏障避孕法的人,但这些结果并不精确,而且可能存在残余混杂因素。
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引用次数: 0
Stop smoking, keep walking, . . . and other stories 戒烟,继续走路,……还有其他的故事
Pub Date : 2023-09-07 DOI: 10.1136/bmj.p1993
The human genome encodes approximately 20 000 proteins. Understandably enough, investigations have concentrated on genes and proteins whose function is known.However, thehuman “unknome,” the one fifth of humangeneswhosepurpose remains mysterious, shouldn’t be ignored. Many of these genes are conserved across species. In experiments with fruit flies, removing one of these mystery genes caused the insects to die. The compilers of a new database of genes with unknown functions hope it will widen the focus of genetic research (PLoS Biol doi:10.1371/journal.pbio.3002222).
人类基因组编码大约2万种蛋白质。可以理解的是,研究集中在功能已知的基因和蛋白质上。然而,人类的“未知”,即五分之一的人类,其目的仍然是神秘的,不应该被忽视。这些基因中的许多在不同物种中都是保守的。在果蝇的实验中,去除其中一个神秘基因会导致果蝇死亡。一个新的未知功能基因数据库的编纂者希望它能拓宽基因研究的焦点(PLoS Biol doi:10.1371/journal.pbio.3002222)。
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引用次数: 0
A persistent sore throat 持续的喉咙痛
Pub Date : 2023-09-07 DOI: 10.1136/bmj-2023-074870
Takanori Yamaguchi, Kei Suzuki
Takanori Yamaguchi, Kei Suzuki This man in his 30s had a sore throat for two months and was initially thought to have viral pharyngitis. He then developed fever and enlarged, painful cervical lymph nodes. On examination, white patches were visible on the soft palate (fig 1). Biopsy of these patches excluded malignancy. Results from serum Treponema pallidumhaemagglutination and rapidplasma reagin (RPR) testswere positive (RPR: 120units) and secondary syphilis was diagnosed. Antibody test results for HIV-1 and 2 were negative. The man had condomless sex and mutual oral sex with a sex worker three months before presentation. He had no other sexual partners and no history of sexually transmitted diseases.
这名30多岁的男子喉咙痛了两个月,最初被认为是病毒性咽炎。随后他出现发烧和颈部淋巴结肿大、疼痛。检查时,软腭可见白色斑块(图1)。这些斑块的活检排除恶性肿瘤。结果血清梅毒螺旋体血球凝集和快速血浆反应素(RPR)试验呈阳性(RPR: 120单位),诊断为二期梅毒。HIV-1和2抗体检测结果均为阴性。该男子在发病前三个月与一名性工作者发生无套性行为并相互口交。他没有其他性伴侣,也没有性传播疾病史。
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引用次数: 0
NSAIDs and contraceptives: critical thinking on a harmful drug interaction 非甾体抗炎药和避孕药:对有害药物相互作用的批判性思考
Pub Date : 2023-09-07 DOI: 10.1136/bmj.p2041
K. Abbasi
As an early career doctor I prescribed diclofenac liberally. It was my go-to anti-inflammatory drug for patients in hospital. My prescribing habit wasn’t influenced by evidence but by learnt behaviour. It was the drug others prescribed. Ibuprofen was one of the other options, and during my stint in rheumatology a consultant hadwarnedmeof people taking ibuprofen “like smarties” but being unaware of the risk of renal failure. If not ibuprofen, then diclofenac, or another non-steroidal anti-inflammatory drug. Perhaps the evidencewasn’t then clear about the effects of prescribing NSAIDs to women using hormonal contraception? Perhaps I should have paid more attention? Perhaps I would have been better served by critical appraisal and knowledge synthesis and translation, skills I had barely acquired?
作为一名早期的职业医生,我大量开具双氯芬酸处方。这是我给住院病人用的消炎药。我开处方的习惯不是受到证据的影响,而是受到后天行为的影响。这是别人开的药。布洛芬是另一种选择,在我从事风湿病学研究期间,一位顾问曾告诉我,有些人“像聪明人一样”服用布洛芬,却没有意识到肾功能衰竭的风险。如果不是布洛芬,那么是双氯芬酸,或者另一种非甾体抗炎药。也许当时的证据还不清楚给使用激素避孕的女性开非甾体抗炎药的效果?也许我应该多注意点?也许批判性评估、知识综合和翻译这些我几乎没有掌握的技能会对我有更好的帮助?
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引用次数: 0
Advances in the management of type 2 diabetes in adults. 成人2型糖尿病治疗进展。
Pub Date : 2023-09-04 eCollection Date: 2023-01-01 DOI: 10.1136/bmjmed-2022-000372
Rodolfo J Galindo, Jennifer M Trujillo, Cecilia C Low Wang, Rozalina G McCoy

Type 2 diabetes is a chronic and progressive cardiometabolic disorder that affects more than 10% of adults worldwide and is a major cause of morbidity, mortality, disability, and high costs. Over the past decade, the pattern of management of diabetes has shifted from a predominantly glucose centric approach, focused on lowering levels of haemoglobin A1c (HbA1c), to a directed complications centric approach, aimed at preventing short term and long term complications of diabetes, and a pathogenesis centric approach, which looks at the underlying metabolic dysfunction of excess adiposity that both causes and complicates the management of diabetes. In this review, we discuss the latest advances in patient centred care for type 2 diabetes, focusing on drug and non-drug approaches to reducing the risks of complications of diabetes in adults. We also discuss the effects of social determinants of health on the management of diabetes, particularly as they affect the treatment of hyperglycaemia in type 2 diabetes.

2型糖尿病是一种慢性进行性心脏代谢紊乱,影响着全球超过10%的成年人,是发病率、死亡率、残疾和高成本的主要原因。在过去的十年里,糖尿病的管理模式已经从主要以葡萄糖为中心的方法转变为以降低血红蛋白A1c(HbA1c)水平为重点的方法,转变为以并发症为中心的直接方法,旨在预防糖尿病的短期和长期并发症,它着眼于过度肥胖的潜在代谢功能障碍,这既导致糖尿病的治疗,又使糖尿病的治疗复杂化。在这篇综述中,我们讨论了以患者为中心的2型糖尿病护理的最新进展,重点是降低成人糖尿病并发症风险的药物和非药物方法。我们还讨论了健康的社会决定因素对糖尿病管理的影响,特别是当它们影响2型糖尿病高血糖的治疗时。
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引用次数: 0
We owe the families affected by Letby meaningful organisational change 我们欠受Letby影响的家庭有意义的组织变革
Pub Date : 2023-08-31 DOI: 10.1136/bmj.p1986
J. Dobson
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引用次数: 2
Patricia Grenfell 帕特丽夏Grenfell
Pub Date : 2023-08-31 DOI: 10.1136/bmj.p1980
Jenny Grenfell-Shaw
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引用次数: 0
Social contact and brain size . . . and other stories 社会交往和大脑大小……还有其他的故事
Pub Date : 2023-08-31 DOI: 10.1136/bmj.p1937
Social isolation has been linked to declining cognitive function and late-life depressive symptoms. In a study of 9000 older adults (≥65 years) living in Japan who had undergone brain MRI scans, it was also associated with lower total brain volume and a higher burden of white matter lesions. Brain regions affected included those known to be involved with memory, mood, and cognition, such as the temporal lobe, hippocampus, and amygdala. (Neurology doi:10.1212/WNL.0000000000207602).
社会孤立与认知功能下降和晚年抑郁症状有关。在一项对9000名日本老年人(≥65岁)进行脑MRI扫描的研究中,它还与总脑容量较低和白质病变负担较高有关。受影响的大脑区域包括那些已知与记忆、情绪和认知有关的区域,如颞叶、海马体和杏仁核。(神经病学doi: 10.1212 / WNL.0000000000207602)。
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引用次数: 0
Pyogenic granuloma of the small intestine 小肠的化脓性肉芽肿
Pub Date : 2023-08-31 DOI: 10.1136/bmj-2022-074142
Shurong Chen, Yi Chen
This double balloon endoscopy image shows a pyogenic granuloma in the small intestine of a man in his 50s (fig 1). He presented with a two year history of melaena and passing shapeless, mucinous stools twice a day, and fatigue for five months. Blood tests showed iron deficiency anaemia (haemoglobin 70 g/L). No lesions were identified on gastroscopy and colonoscopy. Capsule endoscopy, however, indicated a bleeding jejunal mass in the small intestine, and double balloon endoscopy was performed to better locate the mass. The lesion was removed laparoscopically, with pathology confirming pyogenic granuloma. This common benignvasculartumouraffectstheskinormucousmembrane. 1 Althoughrarelyreportedinthegastrointestinal tract, pyogenic granuloma is a differential diagnosis for iron deficiency anaemia in the presence of bloody stools or melaena. 1 2
双球囊内窥镜图像显示50多岁男性小肠化脓性肉芽肿(图1)。他有两年的黑黑病史,每天两次排便不定型,粘液性便,并且疲劳了5个月。血液检查显示缺铁性贫血(血红蛋白70克/升)。胃镜和结肠镜检查均未发现病变。然而,胶囊内镜显示小肠空肠出血肿块,并进行双球囊内镜以更好地定位肿块。腹腔镜下切除病变,病理证实化脓性肉芽肿。这种常见的良性血管肿瘤影响皮肤或粘膜。虽然很少在胃肠道中报道,但化脓性肉芽肿是缺铁性贫血伴血便或黑素瘤的鉴别诊断。1 2
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引用次数: 0
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BMJ medicine
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