BMJ medicine最新文献

{"title":"ADNEX risk prediction model for diagnosis of ovarian cancer: systematic review and meta-analysis of external validation studies.","authors":"Lasai Barreñada, Ashleigh Ledger, Paula Dhiman, Gary Collins, Laure Wynants, Jan Y Verbakel, Dirk Timmerman, Lil Valentin, Ben Van Calster","doi":"10.1136/bmjmed-2023-000817","DOIUrl":"10.1136/bmjmed-2023-000817","url":null,"abstract":"<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:","PeriodicalId":72433,"journal":{"name":"BMJ medicine","volume":"3 1","pages":"e000817"},"PeriodicalIF":0.0,"publicationDate":"2024-02-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10875560/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139907054","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}

{"title":"Association of vaginal oestradiol and the rate of breast cancer in Denmark: registry based, case-control study, nested in a nationwide cohort.","authors":"Amani Meaidi, Nelsan Pourhadi, Ellen Christine Løkkegaard, Christian Torp-Pedersen, Lina Steinrud Mørch","doi":"10.1136/bmjmed-2023-000753","DOIUrl":"10.1136/bmjmed-2023-000753","url":null,"abstract":"<p><strong>Objective: </strong>To estimate the rate of breast cancer associated with use of vaginal oestradiol tablets according to duration and intensity of their use.</p><p><strong>Design: </strong>Registry based, case-control study, nested in a nationwide cohort.</p><p><strong>Setting: </strong>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.</p><p><strong>Participants: </strong>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.</p><p><strong>Main outcome measure: </strong>The main outcome was pathology confirmed breast cancer diagnosis.</p><p><strong>Results: </strong>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).</p><p><strong>Conclusions: </strong>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.</p>","PeriodicalId":72433,"journal":{"name":"BMJ medicine","volume":"3 1","pages":"e000753"},"PeriodicalIF":0.0,"publicationDate":"2024-02-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10868295/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139742836","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}

{"title":"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.","authors":"Thomas Beaney, Jonathan Clarke, Thomas Woodcock, Azeem Majeed, Mauricio Barahona, Paul Aylin","doi":"10.1136/bmjmed-2022-000474","DOIUrl":"10.1136/bmjmed-2022-000474","url":null,"abstract":"<p><strong>Objective: </strong>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.</p><p><strong>Design: </strong>Retrospective study of disease code frequency in primary care electronic health records.</p><p><strong>Data sources: </strong>Routinely collected, general practice, electronic health record data from the Clinical Practice Research Datalink Aurum were used.</p><p><strong>Main outcome measures: </strong>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.</p><p><strong>Results: </strong>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 <i>v</i> 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.</p><p><strong>Conclusions: </strong>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.</p>","PeriodicalId":72433,"journal":{"name":"BMJ medicine","volume":"3 1","pages":"e000474"},"PeriodicalIF":0.0,"publicationDate":"2024-02-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10868275/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139742837","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}

{"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}

{"title":"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.","authors":"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","doi":"10.1136/bmjmed-2023-000588","DOIUrl":"10.1136/bmjmed-2023-000588","url":null,"abstract":"<p><strong>Objective: </strong>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.</p><p><strong>Design: </strong>Single centred, single blinded, randomised, controlled trial (the MySweetheart trial).</p><p><strong>Setting: </strong>Lausanne University Hospital, Switzerland, from 2 September 2016 to 25 October 2021.</p><p><strong>Participants: </strong>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).</p><p><strong>Interventions: </strong>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.</p><p><strong>Main outcome measures: </strong>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.</p><p><strong>Results: </strong>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) <i>v</i> 20.8% (20/96), P=0.034).</p><p><strong>Conclusions: </strong>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.</p><p><strong>Trial ","PeriodicalId":72433,"journal":{"name":"BMJ medicine","volume":"3 1","pages":"e000588"},"PeriodicalIF":0.0,"publicationDate":"2024-02-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10860000/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139725182","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}

{"title":"Design differences and variation in results between randomised trials and non-randomised emulations: meta-analysis of RCT-DUPLICATE data.","authors":"Rachel Heyard, Leonhard Held, Sebastian Schneeweiss, Shirley V Wang","doi":"10.1136/bmjmed-2023-000709","DOIUrl":"10.1136/bmjmed-2023-000709","url":null,"abstract":"<p><strong>Objective: </strong>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).</p><p><strong>Design: </strong>Meta-analysis of RCT-DUPLICATE data.</p><p><strong>Data sources: </strong>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.</p><p><strong>Eligibility criteria for selecting studies: </strong>Trials where the primary analysis resulted in a hazard ratio; 29 RCT-RWE study pairs from RCT-DUPLICATE.</p><p><strong>Results: </strong>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).</p><p><strong>Conclusions: </strong>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.</p>","PeriodicalId":72433,"journal":{"name":"BMJ medicine","volume":"3 1","pages":"e000709"},"PeriodicalIF":0.0,"publicationDate":"2024-02-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10860009/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139725181","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}

{"title":"Post-covid-19 conditions in adults: systematic review and meta-analysis of health outcomes in controlled studies.","authors":"Juan Victor Ariel Franco, Luis Ignacio Garegnani, Maria-Inti Metzendorf, Katharina Heldt, Rebekka Mumm, Christa Scheidt-Nave","doi":"10.1136/bmjmed-2023-000723","DOIUrl":"10.1136/bmjmed-2023-000723","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;To assess the impact of post-covid-19 conditions among adults.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Design: &lt;/strong&gt;Systematic review and meta-analysis of health outcomes in controlled studies.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Data sources: &lt;/strong&gt;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.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Eligibility criteria: &lt;/strong&gt;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.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Data extraction and synthesis: &lt;/strong&gt;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.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;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&lt;sup&gt;2&lt;/sup&gt;=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&lt;sup&gt;2&lt;/sup&gt;=91.96%) and in outpatient care (1.12 (1.01 to 1.24), seven studies, I&lt;sup&gt;2&lt;/sup&gt;=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&lt;sup&gt;2&lt;/sup&gt;=98.91%). Evidence also showed an increased incidence of a wide variety of metabolic, cardiovascular, neurological, respiratory, haematological and other incident diagnoses.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusion: &lt;/strong&gt;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","PeriodicalId":72433,"journal":{"name":"BMJ medicine","volume":"3 1","pages":"e000723"},"PeriodicalIF":0.0,"publicationDate":"2024-01-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10826558/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139643529","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}

{"title":"Covid-19 pandemic and equity of global human papillomavirus vaccination: descriptive study of World Health Organization-Unicef vaccination coverage estimates.","authors":"Rebecca Mary Casey, Hiroki Akaba, Terri B Hyde, Paul Bloem","doi":"10.1136/bmjmed-2023-000726","DOIUrl":"10.1136/bmjmed-2023-000726","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;To analyse progress in global vaccination against human papillomavirus (HPV) during the covid-19 pandemic, with a particular focus on equity.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Design: &lt;/strong&gt;Descriptive study of World Health Organization-Unicef vaccination coverage estimates.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Setting: &lt;/strong&gt;WHO-Unicef estimates of global, regional, and national HPV vaccination coverage, before (2010-19) and during (2020-21) the covid-19 pandemic.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Participants: &lt;/strong&gt;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).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Main outcome measures: &lt;/strong&gt;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.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;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.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;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","PeriodicalId":72433,"journal":{"name":"BMJ medicine","volume":"3 1","pages":"e000726"},"PeriodicalIF":0.0,"publicationDate":"2024-01-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10826539/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139643511","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}

{"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}

{"title":"Transgender identity in young people and adults recorded in UK primary care electronic patient records: retrospective, dynamic, cohort study.","authors":"Douglas Gordon John McKechnie, Elizabeth O'Nions, Julia Bailey, Lorna Hobbs, Frank Gillespie, Irene Petersen","doi":"10.1136/bmjmed-2023-000499","DOIUrl":"10.1136/bmjmed-2023-000499","url":null,"abstract":"<p><strong>Objectives: </strong>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.</p><p><strong>Design: </strong>Retrospective, dynamic, cohort study.</p><p><strong>Setting: </strong>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.</p><p><strong>Participants: </strong>7 064 829 individuals aged 10-99 years, in all four UK countries.</p><p><strong>Main outcome measures: </strong>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.</p><p><strong>Results: </strong>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)).</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":72433,"journal":{"name":"BMJ medicine","volume":"2 1","pages":"e000499"},"PeriodicalIF":0.0,"publicationDate":"2023-11-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10685922/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138464751","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}