Clinical trial–derived risk model may not generalize to real-world patients with acute coronary syndrome

Yan, Andrew T.; Jong, Philip; Yan, Raymond T.; Tan, Mary; Fitchett, David; Chow, Chi-Ming; Roe, Matthew T.; Pieper, Karen S.; Langer, Anatoly

doi:10.1016/j.ahj.2004.02.014

Cited by 84 publications

(42 citation statements)

References 29 publications

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“…97 For instance, a risk model derived from a more heterogeneous case mix provided better calibration in risk assessment across the spectrum of acute coronary syndromes than another model derived using a clinical trial population, although both models showed similar discriminatory ability. 98 …”

Section: Model Validationmentioning

confidence: 99%

Surveillance for ocular hypertension: an evidence synthesis and economic evaluation.

Burr

Botello-Pinzon²,

Takwoingi³

et al. 2012

Health Technol Assess

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How to obtain copies of this and other HTA programme reports An electronic version of this title, in Adobe Acrobat format, is available for downloading free of charge for personal use from the HTA website (www.hta.ac.uk). A fully searchable DVD is also available (see below).Printed copies of HTA journal series issues cost £20 each (post and packing free in the UK) to both public and private sector purchasers from our despatch agents.Non-UK purchasers will have to pay a small fee for post and packing. For European countries the cost is £2 per issue and for the rest of the world £3 per issue. How to order:-fax (with credit card details) -post (with credit card details or cheque) -phone during office hours (credit card only).Additionally the HTA website allows you to either print out your order or download a blank order form. Contact details are as follows:Synergie UK (HTA Department) Digital House, The Loddon Centre Wade Road Basingstoke Hants RG24 8QW Email: orders@hta.ac.uk Tel: 0845 812 4000 -ask for 'HTA Payment Services' (out-of-hours answer-phone service) Fax: 0845 812 4001 -put 'HTA Order' on the fax header Payment methods Paying by chequeIf you pay by cheque, the cheque must be in pounds sterling, made payable to University of Southampton and drawn on a bank with a UK address.Paying by credit card You can order using your credit card by phone, fax or post. SubscriptionsNHS libraries can subscribe free of charge. Public libraries can subscribe at a reduced cost of £100 for each volume (normally comprising 40-50 titles). The commercial subscription rate is £400 per volume (addresses within the UK) and £600 per volume (addresses outside the UK). Please see our website for details. Subscriptions can be purchased only for the current or forthcoming volume.How do I get a copy of HTA on DVD?Please use the form on the HTA website (www.hta.ac.uk/htacd/index.shtml). HTA on DVD is currently free of charge worldwide.The website also provides information about the HTA programme and lists the membership of the various committees. HTA NIHR Health Technology Assessment programmeThe Health Technology Assessment (HTA) programme, part of the National Institute for Health Research (NIHR), was set up in 1993. It produces high-quality research information on the effectiveness, costs and broader impact of health technologies for those who use, manage and provide care in the NHS. 'Health technologies' are broadly defined as all interventions used to promote health, prevent and treat disease, and improve rehabilitation and long-term care. The research findings from the HTA programme directly influence decision-making bodies such as the National Institute for Health and Clinical Excellence (NICE) and the National Screening Committee (NSC). HTA findings also help to improve the quality of clinical practice in the NHS indirectly in that they form a key component of the 'National Knowledge Service' . The HTA programme is needs led in that it fills gaps in the evidence needed by the NHS. There are three routes to the start of projects...

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Section: Model Validationmentioning

confidence: 99%

Surveillance for ocular hypertension: an evidence synthesis and economic evaluation.

Burr

Botello-Pinzon²,

Takwoingi³

et al. 2012

Health Technol Assess

View full text Add to dashboard Cite

show abstract

“…Our data underscore the importance of risk model validation in an appropriate target population rather than a clinical trial population to establish its generalizability before integration into clinical practice. 29 So how can we best expedite management of the low to intermediate risk patient who presents to the ED with chest pain? Patients who present with chest pain that can be attributed to a non-cardiac cause should require no further cardiac testing.…”

Section: Discussionmentioning

confidence: 99%

Cardiac risk factors and risk scores vs cardiac computed tomography angiography: a prospective cohort study for triage of ED patients with acute chest pain

Halpern

Deutsch

Hannaway

et al. 2013

The American Journal of Emergency Medicine

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“…363 Clinical registries address some of the selection bias and are valuable resources for comparison and for assessing trends in treatment. [363][364][365][366][367] The finding of similarly high PCI rates in an unselected (SWEDEHEART/RIKS-HIA) and a selected (ACTION) registry makes the differences seen in other aspects of NSTEMI care more informative. It suggests that US procedure rates are not being driven by fee for service and that Sweden's increased emphasis on system-wide quality improvement is bearing fruit.…”

Section: Discussionmentioning

confidence: 99%

Using nationwide ‘big data’ from linked electronic health records to help improve outcomes in cardiovascular diseases: 33 studies using methods from epidemiology, informatics, economics and social science in the ClinicAl disease research using LInked Bespoke studies and Electronic health Records (CALIBER) programme

Hemingway

Feder

Denaxas

et al. 2017

Programme Grants Appl Res

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BackgroundElectronic health records (EHRs), when linked across primary and secondary care and curated for research use, have the potential to improve our understanding of care quality and outcomes.ObjectiveTo evaluate new opportunities arising from linked EHRs for improving quality of care and outcomes for patients at risk of or with coronary disease across the patient journey.DesignEpidemiological cohort, health informatics, health economics and ethnographic approaches were used.Setting230 NHS hospitals and 226 general practices in England and Wales.ParticipantsUp to 2 million initially healthy adults, 100,000 people with stable coronary artery disease (SCAD) and up to 300,000 patients with acute coronary syndrome.Main outcome measuresQuality of care, fatal and non-fatal cardiovascular disease (CVD) events.Data platform and methodsWe created a novel research platform [ClinicAl disease research using LInked Bespoke studies and Electronic health Records (CALIBER)] based on linkage of four major sources of EHR data in primary care and national registries. We carried out 33 complementary studies within the CALIBER framework. We developed a web-based clinical decision support system (CDSS) in hospital chest pain clinics. We established a novel consented prognostic clinical cohort of SCAD patients.ResultsCALIBER was successfully established as a valid research platform based on linked EHR data in nearly 2 million adults with > 600 EHR phenotypes implemented on the web portal (seehttps://caliberresearch.org/portal). Despite national guidance, key opportunities for investigation and treatment were missed across the patient journey, resulting in a worse prognosis for patients in the UK compared with patients in health systems in other countries. Our novel, contemporary, high-resolution studies showed heterogeneous associations for CVD risk factors across CVDs. The CDSS did not alter the decision-making behaviour of clinicians in chest pain clinics. Prognostic models using real-world data validly discriminated risk of death and events, and were used in cost-effectiveness decision models.ConclusionsEmerging ‘big data’ opportunities arising from the linkage of records at different stages of a patient’s journey are vital to the generation of actionable insights into the diagnosis, risk stratification and cost-effective treatment of people at risk of, or with, CVD.Future workThe vast majority of NHS data remain inaccessible to research and this hampers efforts to improve efficiency and quality of care and to drive innovation. We propose three priority directions for further research. First, there is an urgent need to ‘unlock’ more detailed data within hospitals for the scale of the UK’s 65 million population. Second, there is a need for scaled approaches to using EHRs to design and carry out trials, and interpret the implementation of trial results. Third, large-scale, disease agnostic genetic and biological collections linked to such EHRs are required in order to deliver precision medicine and to innovate discovery.Study registrationCALIBER studies are registered as follows: study 2 – NCT01569139, study 4 – NCT02176174 and NCT01164371, study 5 – NCT01163513, studies 6 and 7 – NCT01804439, study 8 – NCT02285322, and studies 26–29 – NCT01162187. Optimising the Management of Angina is registered as Current Controlled Trials ISRCTN54381840.FundingThe National Institute for Health Research (NIHR) Programme Grants for Applied Research programme (RP-PG-0407-10314) (all 33 studies) and additional funding from the Wellcome Trust (study 1), Medical Research Council Partnership grant (study 3), Servier (study 16), NIHR Research Methods Fellowship funding (study 19) and NIHR Research for Patient Benefit (study 33).

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Clinical trial–derived risk model may not generalize to real-world patients with acute coronary syndrome

Cited by 84 publications

References 29 publications

Surveillance for ocular hypertension: an evidence synthesis and economic evaluation.

Surveillance for ocular hypertension: an evidence synthesis and economic evaluation.

Cardiac risk factors and risk scores vs cardiac computed tomography angiography: a prospective cohort study for triage of ED patients with acute chest pain

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