scholarly journals Predicting prostate cancer progression: protocol for a retrospective cohort study to identify prognostic factors for prostate cancer outcomes using routine primary care data

BMJ Open ◽  
2018 ◽  
Vol 8 (1) ◽  
pp. e019409 ◽  
Author(s):  
Samuel W D Merriel ◽  
Margaret T May ◽  
Richard M Martin
Keyword(s):  
Prostate Cancer ◽  
Prognostic Factors ◽  
Cancer Progression ◽  
Practice Research ◽  
Cancer Registration ◽  
Clinical Practice Research Datalink ◽  
Gleason Grade ◽  
Prostate Cancer Progression ◽  
The Uk

IntroductionProstate cancer is the most common cancer in men in the UK, with nearly 40 000 diagnosed in 2014; and it is the second most common cause of male cancer-related mortality. The clinical conundrum is that most men live with prostate cancer rather than die from it, while existing treatments have significant associated morbidity. Recent studies have shown very low mortality rates (1% after a median of 10-year follow-up) and no treatment-related reductions in mortality, in men with localised prostate cancer. This study will identify prognostic factors associated with prostate cancer progression to help differentiate aggressive from more indolent tumours in men with localised disease at diagnosis, and so inform the decision to adopt conservative (active surveillance) or radical (surgery or radiotherapy) management strategies.Methods and analysisThe Clinical Practice Research Datalink (CPRD) contains 57 318 men who were diagnosed with prostate cancer between 1 January 1987 and 31 December 2016. These men will be linked to the Office for National Statistics (ONS) and the National Cancer Registration and Analysis Service registry databases for mortality, TNM stage, Gleason grade and treatment data. Men with a diagnosis date prior to 1 January 1987 and men with lymph node or distant metastases at diagnosis will be excluded. A priori determined prognostic factors potentially associated with prostate cancer mortality, the end point of cancer progression, will be measured at baseline, and the participants followed through to development of cancer progression, death or the end of the follow-up period (31 December 2016). Cox proportional hazards regression will be used to estimate crude and mutually adjusted HRs. Mortality risk will be predicted using flexible parametric survival models that can accurately fit the shape of the hazard function.Ethics and disseminationThis study protocol has approval from the Independent Scientific Advisory Committee for the UK Medicines and Healthcare products Regulatory Agency Database Research (protocol 17_041). The findings will be presented in peer-reviewed journals and local CPRD researcher meetings.

Therapy persistence in newly diagnosed non-valvular atrial fibrillation treated with warfarin or NOAC

2016 ◽  
Vol 115 (01) ◽  
pp. 31-39 ◽  
Author(s):  
Anja Katholing ◽  
Christopher Wallenhorst ◽  
Saul Benedict Freedman ◽  
Carlos Martinez
Keyword(s):  
Atrial Fibrillation ◽  
Guideline Adherence ◽  
Practice Research ◽  
First Year ◽  
Clinical Practice Research Datalink ◽  
Supplementary Material ◽  
One Year ◽  
The Uk ◽  
Physician Adherence

SummaryEfforts to reduce stroke in atrial fibrillation (AF) have focused on increasing physician adherence to oral anticoagulant (OAC) guidelines, but high early vitamin K antagonist (VKA) discontinuation is a limitation. We compared persistence of non-VKA OAC (NOAC) with VKA treatment in the first year after OAC inception for incident AF in real-world practice. We studied 27,514 anticoagulant-naïve patients with incident non-valvular AF between January 2011 and May 2014 in the UK primary care Clinical Practice Research Datalink, with full medication use linkage: mean age 74.2 ± 12.4, 45.7 % female, mean follow-up 1.9 ± 1.1 years. After treatment initiation and follow-up until 1/2015, the proportion remaining on OAC at one year (persistence) was estimated using competing risk survival analyses. OAC was commenced ≤90 days after incident AF in 13,221 patients (48.1 %): 12,307 VKA and 914 NOAC (apixaban, dabigatran, rivaroxaban). Amongst those treated with OAC, the proportion commencing NOAC increased from zero in 1/2011 to 27.0 % in 5/2014, and OAC prescriptions for CHA2DS2VASc score ≥2 (guideline adherence) increased from 41.2 % to 65.5 %. Persistence with OAC declined over 12 months to 63.6 % for VKA and 79.2 % for NOAC (p< 0.0001). Persistence for those with CHA2DS2VASc ≥2 was significantly greater for NOAC (83.0 %) than VKA (65.3 %, p< 0.0001) at one year and all earlier time points. Comparison of VKA and NOAC cohorts matched on individual CHA2DS2VASc components showed consistent results. In conclusion, persistence was significantly higher with NOAC than VKA, and could alone lead to fewer cardioembolic strokes. Increased guideline adherence following NOAC introduction could further decrease AF stroke burden.Supplementary Material to this article is available online at www.thrombosis-online.com.

INHIBITION OF HUMAN PROSTATE CANCER PROGRESSION BY ADMINISTRATION OF GREEN TEA CATECHINS: A TWO YEARS LATER FOLLOW-UP UPDATE

2008 ◽  
Vol 179 (4S) ◽  
pp. 224-224 ◽  
Author(s):  
Brausi Maurizio ◽  
Bettuzzi Saverio ◽  
Peracchia Giancarlo ◽  
Rizzi Federica ◽  
Corti Arnaldo
Keyword(s):  
Prostate Cancer ◽  
Green Tea ◽  
Cancer Progression ◽  
Human Prostate ◽  
Human Prostate Cancer ◽  
Prostate Cancer Progression ◽  
Tea Catechins ◽  
Green Tea Catechins

scholarly journals Realising the full potential of data-enabled trials in the UK: a call for action

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e043906
Author(s):  
Matthew R Sydes ◽  
Yolanda Barbachano ◽  
Louise Bowman ◽  
Tom Denwood ◽  
Andrew Farmer ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Case Studies ◽  
Outcome Measures ◽  
Data Science ◽  
Practice Research ◽  
Clinical Practice Research Datalink ◽  
Full Potential ◽  
National Workshop ◽  
The Uk

RationaleClinical trials are the gold standard for testing interventions. COVID-19 has further raised their public profile and emphasised the need to deliver better, faster, more efficient trials for patient benefit. Considerable overlap exists between data required for trials and data already collected routinely in electronic healthcare records (EHRs). Opportunities exist to use these in innovative ways to decrease duplication of effort and speed trial recruitment, conduct and follow-up.ApproachThe National Institute of Health Research (NIHR), Health Data Research UK and Clinical Practice Research Datalink co-organised a national workshop to accelerate the agenda for ‘data-enabled clinical trials’. Showcasing successful examples and imagining future possibilities, the plenary talks, panel discussions, group discussions and case studies covered: design/feasibility; recruitment; conduct/follow-up; collecting benefits/harms; and analysis/interpretation.ReflectionSome notable studies have successfully accessed and used EHR to identify potential recruits, support randomised trials, deliver interventions and supplement/replace trial-specific follow-up. Some outcome measures are already reliably collected; others, like safety, need detailed work to meet regulatory reporting requirements. There is a clear need for system interoperability and a ‘route map’ to identify and access the necessary datasets. Researchers running regulatory-facing trials must carefully consider how data quality and integrity would be assessed. An experience-sharing forum could stimulate wider adoption of EHR-based methods in trial design and execution.DiscussionEHR offer opportunities to better plan clinical trials, assess patients and capture data more efficiently, reducing research waste and increasing focus on each trial’s specific challenges. The short-term emphasis should be on facilitating patient recruitment and for postmarketing authorisation trials where research-relevant outcome measures are readily collectable. Sharing of case studies is encouraged. The workshop directly informed NIHR’s funding call for ambitious data-enabled trials at scale. There is the opportunity for the UK to build upon existing data science capabilities to identify, recruit and monitor patients in trials at scale.

scholarly journals Co-prescription of gabapentinoids and opioids among adults with and without osteoarthritis in the United Kingdom between 1995 and 2017

Rheumatology ◽  
2020 ◽  
Author(s):  
Dahai Yu ◽  
Tom Appleyard ◽  
Elizabeth Cottrell ◽  
George Peat
Keyword(s):  
Event Rate ◽  
Practice Research ◽  
Clinical Practice Research Datalink ◽  
The United Kingdom ◽  
Regional Estimates ◽  
Strong Opioids ◽  
The Uk ◽  
New Diagnosis

Abstract Objectives To produce national and regional estimates and trends for gabapentinoid–opioid co-prescribing rates in patients with OA, both in absolute terms and relative to matched controls without OA. Methods Using the UK Clinical Practice Research Datalink database we first constructed age–sex–practice–date 1:1 matched cohorts of patients aged ≥40 years with and without a new diagnosis of OA between 1995–2017 and estimated the relative incidence of a first gabapentinoid prescription. Incident gabapentinoid users in both cohorts were followed to estimate and compare the event rate of gabapentinoid–opioid co-prescription (prescription from both classes within the same 28-day window). Results The incidence of first gabapentinoid prescription was 3-fold higher in patients with OA than in matched controls [n = 215 357; incidence rate ratio (IRR) 2.93; 95% CI: 2.87, 3.00]. Among incident gabapentinoid users with OA (n = 27 374, median follow-up 3.9 years) the event rate of gabapentinoid–opioid co-prescription was 4.03 (4.02–4.05) per person-year. The rate was higher in OA patients classed as long-term gabapentinoid users (6.24; 6.22–6.26). These rates were significantly higher than in incident gabapentinoid users without OA [adjusted-IRR: 1.29 (1.28–1.30)]. This elevated risk was observed across age, sex, geographic regions, and calendar years, when restricted to strong opioids and to long-term gabapentinoid users, and when co-prescription was defined as within 14 days and same-day prescribing. Conclusions Patients with OA not only have a higher risk of being prescribed a gabapentinoid but, once prescribed a gabapentinoid, are also at greater risk of opioid co-prescription. Strict restriction of gabapentinoid–opioid co-prescription, and improved access to, and uptake of, effective non-pharmacological and surgical alternatives for OA are required.

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