BMJ medicine最新文献_第7页

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。

BMJ medicine 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

{"title":"Transparent reporting of adaptive clinical trials using concurrently randomised cohorts.","authors":"Ian C Marschner, Mark Jones, James A Totterdell, Robert K Mahar, Thomas L Snelling, Steven Y C Tong","doi":"10.1136/bmjmed-2023-000497","DOIUrl":"10.1136/bmjmed-2023-000497","url":null,"abstract":"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.","PeriodicalId":72433,"journal":{"name":"BMJ medicine","volume":"2 1","pages":"e000497"},"PeriodicalIF":0.0,"publicationDate":"2023-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/7f/d4/bmjmed-2023-000497.PMC10510920.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41175421","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

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。

BMJ medicine 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

{"title":"Preconception contraceptive use and miscarriage: prospective cohort study.","authors":"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","doi":"10.1136/bmjmed-2023-000569","DOIUrl":"10.1136/bmjmed-2023-000569","url":null,"abstract":"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.","PeriodicalId":72433,"journal":{"name":"BMJ medicine","volume":"2 1","pages":"e000569"},"PeriodicalIF":0.0,"publicationDate":"2023-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/f2/d0/bmjmed-2023-000569.PMC10496668.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10626432","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

Stop smoking, keep walking, . . . and other stories 戒烟，继续走路，……还有其他的故事

BMJ medicine Pub Date : 2023-09-07 DOI: 10.1136/bmj.p1993