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  • 1
    Online Resource
    Online Resource
    Development of predictive genetic tests for improving the safety of new medicines: the utilization of routinely collected electronic health records
    Elsevier BV ; 2014
    In:  Drug Discovery Today Vol. 19, No. 4 ( 2014-04), p. 361-366
    Details
    In: Drug Discovery Today, Elsevier BV, Vol. 19, No. 4 ( 2014-04), p. 361-366
    Type of Medium: Online Resource
    ISSN: 1359-6446
    URL: Article
    DOI: 10.1016/j.drudis.2013.11.003
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2014
    detail.hit.zdb_id: 1500337-1
    SSG: 15,3
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  • 2
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    Cardiovascular disease risk in survivors of 20 adult cancers.
    American Society of Clinical Oncology (ASCO) ; 2019
    In:  Journal of Clinical Oncology Vol. 37, No. 15_suppl ( 2019-05-20), p. 11571-11571
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 37, No. 15_suppl ( 2019-05-20), p. 11571-11571
    Abstract: 11571 Background: There are concerns about long-term cardiovascular disease (CVD) risk in cancer survivors, but few studies have quantified the risks for a wide range of cancers and specific CVD outcomes. Methods: Using UK electronic health records, we identified cohorts of adults alive one year after a cancer diagnosis at 20 different sites. Risks of a range of CVD outcomes were compared to age, sex and general practice matched cancer free controls using Cox regression; crude and adjusted models were compared to investigate the role of shared cancer/CVD risk factors (e.g. smoking and diabetes). Results: 126 120 cancer survivors and 603 144 controls were followed over a median (IQR) 4.6 (2.5-8.1) and 5.6 (3.2-9.2) years. Crude and adjusted hazard ratios (HRs) were similar. In adjusted models, there was strong evidence (p 〈 0.01) of increased risk of CVDs among cancer survivors compared with controls: venous thromboembolism (VTE, 18 cancers), heart failure/cardiomyopathy (7 cancers), arrhythmia (4 cancers), and stroke (3 cancers). In stratified analyses HRs were higher in younger people and continued beyond 5 years post diagnosis. Conclusions: We found increased long term CVD risk among survivors of several cancers compared to the general population, which varied by cancer site and specific CVD outcome.[Table: see text]
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2019.37.15_suppl.11571
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2019
    detail.hit.zdb_id: 2005181-5
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  • 3
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    Long term adjuvant endocrine therapy and risk of cardiovascular disease in female breast cancer survivors: systematic review
    BMJ ; 2018
    In:  BMJ
    Details
    In: BMJ, BMJ
    Abstract: To investigate the effect of endocrine therapies on a wide range of specific clinical cardiovascular disease outcomes in women with a history of non-metastatic breast cancer. Design Systematic review and meta-analysis of randomised controlled trials and observational studies. Data sources Medline and Embase up until June 2018. Eligibility criteria for selecting studies Studies were included if they investigated the risk of a specific cardiovascular disease outcome associated with use of either tamoxifen or an aromatase inhibitor, or compared the two treatments, in women with a history of non-metastatic breast cancer. Appraisal and data extraction Relevant studies were originally identified and results extracted by one researcher, with a full replication of the study identification process by a combination of two other researchers. The Cochrane Collaboration’s tool for assessing risk of bias was used to assess risk of bias in randomised controlled trials, and this tool was adapted to assess risk of bias in observational studies. Results 26 studies were identified, with results for seven specific cardiovascular disease outcomes (venous thromboembolism, myocardial infarction, stroke, angina, heart failure, arrhythmia, and peripheral vascular disease). Results suggested an increased risk of venous thromboembolism in tamoxifen users compared with both non-users and aromatase inhibitor users. Results were also consistent with a higher risk of the vascular diseases myocardial infarction and angina in aromatase inhibitor users compared with tamoxifen users, but there was also a suggestion that this may be partly driven by a protective effect of tamoxifen on these outcomes. Data were limited, and evidence was generally inconsistent for all other cardiovascular disease outcomes. Conclusion This review has collated substantial randomised controlled trial and observational evidence on the effect of endocrine therapies on several specific cardiovascular disease outcomes including venous thromboembolism and myocardial infarction, progressing knowledge. Although the choice of aromatase inhibitor or tamoxifen will primarily be based on the effectiveness against the recurrence of breast cancer, this review shows that the individual patient’s risk of venous or arterial vascular disease should be an important secondary consideration. Systematic review registration Prospero CRD42017065944.
    Type of Medium: Online Resource
    ISSN: 0959-8138 , 1756-1833
    URL: Article
    DOI: 10.1136/bmj.k3845
    Language: English
    Publisher: BMJ
    Publication Date: 2018
    detail.hit.zdb_id: 1479799-9
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  • 4
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    Body-mass index and risk of 22 specific cancers: a population-based cohort study of 5·24 million UK adults
    Elsevier BV ; 2014
    In:  The Lancet Vol. 384, No. 9945 ( 2014-08), p. 755-765
    Details
    In: The Lancet, Elsevier BV, Vol. 384, No. 9945 ( 2014-08), p. 755-765
    Type of Medium: Online Resource
    ISSN: 0140-6736
    URL: Article
    DOI: 10.1016/S0140-6736(14)60892-8
    RVK:
    XA 10000
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2014
    detail.hit.zdb_id: 2067452-1
    detail.hit.zdb_id: 3306-6
    detail.hit.zdb_id: 1476593-7
    SSG: 5,21
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  • 5
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    HbA1c and brain health across the entire glycaemic spectrum
    Wiley ; 2021
    In:  Diabetes, Obesity and Metabolism Vol. 23, No. 5 ( 2021-05), p. 1140-1149
    Details
    In: Diabetes, Obesity and Metabolism, Wiley, Vol. 23, No. 5 ( 2021-05), p. 1140-1149
    Abstract: To understand the relationship between HbA1c and brain health across the entire glycaemic spectrum. Materials and Methods We used data from the UK Biobank cohort consisting of 500,000 individuals aged 40–69 years. HbA1c and diabetes diagnosis were used to define baseline glycaemic categories. Our outcomes included incident all‐cause dementia, vascular dementia (VD), Alzheimer's dementia (AD), hippocampal volume (HV), white matter hyperintensity (WMH) volume, cognitive function and decline. The reference group was normoglycaemic individuals (HbA1c ≥35 & 〈 42 mmol/mol). Our maximum analytical sample contained 449,973 individuals with complete data. Results Prediabetes and known diabetes increased incident VD (HR 1.54; 95% CI = 1.04, 2.28 and HR 2.97; 95% CI = 2.26, 3.90, respectively). Known diabetes increased all‐cause and AD risk (HR 1.91; 95% CI = 1.66, 2.21 and HR 1.84; 95% CI = 1.44, 2.36, respectively). Prediabetes and known diabetes elevated the risks of cognitive decline (OR 1.42; 1.48, 2.96 and OR 1.39; 1.04, 1.75, respectively). Prediabetes, undiagnosed and known diabetes conferred higher WMH volumes (3%, 22% and 7%, respectively) and lower HV (36, 80 and 82 mm 3 , respectively), whereas low‐normal HbA1c had 1% lower WMH volume and 12 mm 3 greater HV. Conclusion Both prediabetes and known diabetes are harmful in terms of VD, cognitive decline and AD risks, as well as lower HV. Associations appeared to be somewhat driven by antihypertensive medication, which implies that certain cardiovascular drugs may ameliorate some of the excess risk. Low‐normal HbA1c levels, however, are associated with more favourable brain health outcomes and warrant more in‐depth investigation.
    Type of Medium: Online Resource
    ISSN: 1462-8902 , 1463-1326
    URL: Issue
    URL: Article
    DOI: 10.1111/dom.v23.5
    DOI: 10.1111/dom.14321
    Language: English
    Publisher: Wiley
    Publication Date: 2021
    detail.hit.zdb_id: 2004918-3
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  • 6
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    Body mass index and Hodgkin's lymphoma: UK population-based cohort study of 5.8 million individuals
    Springer Science and Business Media LLC ; 2019
    In:  British Journal of Cancer Vol. 120, No. 7 ( 2019-4), p. 768-770
    Details
    In: British Journal of Cancer, Springer Science and Business Media LLC, Vol. 120, No. 7 ( 2019-4), p. 768-770
    Type of Medium: Online Resource
    ISSN: 0007-0920 , 1532-1827
    URL: Article
    DOI: 10.1038/s41416-019-0401-1
    RVK:
    XA 33500
    RVK:
    XA 10000
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2019
    detail.hit.zdb_id: 2002452-6
    detail.hit.zdb_id: 80075-2
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  • 7
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    Optimising case detection within UK electronic health records: use of multiple linked databases for detecting liver injury
    BMJ ; 2016
    In:  BMJ Open Vol. 6, No. 9 ( 2016-09), p. e012102-
    Details
    In: BMJ Open, BMJ, Vol. 6, No. 9 ( 2016-09), p. e012102-
    Type of Medium: Online Resource
    ISSN: 2044-6055 , 2044-6055
    URL: Article
    DOI: 10.1136/bmjopen-2016-012102
    Language: English
    Publisher: BMJ
    Publication Date: 2016
    detail.hit.zdb_id: 2599832-8
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  • 8
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    Use of real-world evidence in postmarketing medicines regulation in the European Union: a systematic assessment of European Medicines Agency referrals 2013–2017
    BMJ ; 2019
    In:  BMJ Open Vol. 9, No. 10 ( 2019-10), p. e028133-
    Details
    In: BMJ Open, BMJ, Vol. 9, No. 10 ( 2019-10), p. e028133-
    Abstract: To assess the use, and evaluate the usefulness, of non-interventional studies and routinely collected healthcare data in postmarketing assessments conducted by the European Medicines Agency (EMA). Design We reviewed and systematically assessed all referrals to the EMA made due to safety or efficacy concerns that were evaluated between 1 January 2013 and 30 June 2017. We extracted information from the assessment report and the referral notification. Two reviewers independently assessed the contribution of non-interventional evidence to decision-making. Results The preliminary evidence leading to the assessment in 52 eligible referrals was mostly from spontaneous reports (cited in 26 of 52 referrals) and randomised trials (22/52). In contrast, many evidence types were used for the full assessment. Non-interventional studies were frequently used in the full assessment for the evaluation of product safety (31/52) and product efficacy (18/52). In particular, non-interventional studies were relied on for the evaluation of safety and efficacy in subgroups, the evaluation of safety relating to a rare adverse event, understanding product usage and misuse and for evaluation of the effectiveness of risk minimisation measures. The most common recommendations were changes to product information (43/52) and marketing authorisation withdrawal or suspension (12/52). In the majority of referrals, non-interventional evidence was judged to contribute to the decision made (30/52) and in three referrals it was the primary source of evidence. Conclusions European regulatory decision-making relies on multiple evidence types, particularly randomised trials, spontaneous reports and non-interventional studies. Non-interventional studies had an important role particularly for the characterisation and quantification of adverse events, the evaluation of product usage and for evaluating the effectiveness of regulatory action to minimise risk.
    Type of Medium: Online Resource
    ISSN: 2044-6055 , 2044-6055
    URL: Article
    DOI: 10.1136/bmjopen-2018-028133
    Language: English
    Publisher: BMJ
    Publication Date: 2019
    detail.hit.zdb_id: 2599832-8
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  • 9
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    Association between warfarin and COVID-19-related outcomes compared with direct oral anticoagulants: population-based cohort study
    Springer Science and Business Media LLC ; 2021
    In:  Journal of Hematology & Oncology Vol. 14, No. 1 ( 2021-12)
    Details
    In: Journal of Hematology & Oncology, Springer Science and Business Media LLC, Vol. 14, No. 1 ( 2021-12)
    Abstract: Thromboembolism has been reported as a consequence of severe COVID-19. Although warfarin is a commonly used anticoagulant, it acts by antagonising vitamin K, which is low in patients with severe COVID-19. To date, the clinical evidence on the impact of regular use of warfarin on COVID-19-related thromboembolism is lacking. Methods On behalf of NHS England, we conducted a population-based cohort study investigating the association between warfarin and COVID-19 outcomes compared with direct oral anticoagulants (DOACs). We used the OpenSAFELY platform to analyse primary care data and pseudonymously linked SARS-CoV-2 antigen testing data, hospital admissions and death records from England. We used Cox regression to estimate hazard ratios (HRs) for COVID-19-related outcomes comparing warfarin with DOACs in people with non-valvular atrial fibrillation. We also conducted negative control outcome analyses (being tested for SARS-CoV-2 and non-COVID-19 death) to assess the potential impact of confounding. Results A total of 92,339 warfarin users and 280,407 DOAC users were included. We observed a lower risk of all outcomes associated with warfarin versus DOACs [testing positive for SARS-CoV-2, HR 0.73 (95% CI 0.68–0.79); COVID-19-related hospital admission, HR 0.75 (95% CI 0.68–0.83); COVID-19-related deaths, HR 0.74 (95% CI 0.66–0.83)]. A lower risk of negative control outcomes associated with warfarin versus DOACs was also observed [being tested for SARS-CoV-2, HR 0.80 (95% CI 0.79–0.81); non-COVID-19 deaths, HR 0.79 (95% CI 0.76–0.83)] . Conclusions Overall, this study shows no evidence of harmful effects of warfarin on severe COVID-19 disease.
    Type of Medium: Online Resource
    ISSN: 1756-8722
    URL: Article
    DOI: 10.1186/s13045-021-01185-0
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2021
    detail.hit.zdb_id: 2429631-4
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  • 10
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    Risks of covid-19 hospital admission and death for people with learning disability: population based cohort study using the OpenSAFELY platform
    BMJ ; 2021
    In:  BMJ
    Details
    In: BMJ, BMJ
    Abstract: To assess the association between learning disability and risk of hospital admission and death from covid-19 in England among adults and children. Design Population based cohort study on behalf of NHS England using the OpenSAFELY platform. Setting Patient level data were obtained for more than 17 million people registered with a general practice in England that uses TPP software. Electronic health records were linked with death data from the Office for National Statistics and hospital admission data from NHS Secondary Uses Service. Participants Adults (aged 16-105 years) and children ( 〈 16 years) from two cohorts: wave 1 (registered with a TPP practice as of 1 March 2020 and followed until 31 August 2020); and wave 2 (registered 1 September 2020 and followed until 8 February 2021). The main exposure group consisted of people on a general practice learning disability register; a subgroup was defined as those having profound or severe learning disability. People with Down’s syndrome and cerebral palsy were identified (whether or not they were on the learning disability register). Main outcome measure Covid-19 related hospital admission and covid-19 related death. Non-covid-19 deaths were also explored. Results For wave 1, 14 312 023 adults aged ≥16 years were included, and 90 307 (0.63%) were on the learning disability register. Among adults on the register, 538 (0.6%) had a covid-19 related hospital admission; there were 222 (0.25%) covid-19 related deaths and 602 (0.7%) non-covid deaths. Among adults not on the register, 29 781 (0.2%) had a covid-19 related hospital admission; there were 13 737 (0.1%) covid-19 related deaths and 69 837 (0.5%) non-covid deaths. Wave 1 hazard ratios for adults on the learning disability register (adjusted for age, sex, ethnicity, and geographical location) were 5.3 (95% confidence interval 4.9 to 5.8) for covid-19 related hospital admission and 8.2 (7.2 to 9.4) for covid-19 related death. Wave 2 produced similar estimates. Associations were stronger among those classified as having severe to profound learning disability, and among those in residential care. For both waves, Down’s syndrome and cerebral palsy were associated with increased hazards for both events; Down’s syndrome to a greater extent. Hazard ratios for non-covid deaths followed similar patterns with weaker associations. Similar patterns of increased relative risk were seen for children, but covid-19 related deaths and hospital admissions were rare, reflecting low event rates among children. Conclusions People with learning disability have markedly increased risks of hospital admission and death from covid-19, over and above the risks observed for non-covid causes of death. Prompt access to covid-19 testing and healthcare is warranted for this vulnerable group, and prioritisation for covid-19 vaccination and other targeted preventive measures should be considered.
    Type of Medium: Online Resource
    ISSN: 1756-1833
    URL: Article
    DOI: 10.1136/bmj.n1592
    Language: English
    Publisher: BMJ
    Publication Date: 2021
    detail.hit.zdb_id: 1479799-9
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