Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The . gov means it’s official. Federal government websites often end in VSports app下载. gov or . mil. Before sharing sensitive information, make sure you’re on a federal government site. .

Https

The site is secure. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. V体育官网.

Randomized Controlled Trial
. 2011 Oct 3:343:d5888.
doi: 10.1136/bmj.d5888.

"V体育官网" Estimating treatment effects for individual patients based on the results of randomised clinical trials

Johannes A N Dorresteijn  1 , Frank L J Visseren, Paul M Ridker, Annemarie M J Wassink, Nina P Paynter, Ewout W Steyerberg, Yolanda van der Graaf, Nancy R Cook
Affiliations
Randomized Controlled Trial

Estimating treatment effects for individual patients based on the results of randomised clinical trials

"V体育官网入口" Johannes A N Dorresteijn et al. BMJ. .

Abstract

Objectives: To predict treatment effects for individual patients based on data from randomised trials, taking rosuvastatin treatment in the primary prevention of cardiovascular disease as an example, and to evaluate the net benefit of making treatment decisions for individual patients based on a predicted absolute treatment effect VSports手机版. .

Setting: As an example, data were used from the Justification for the Use of Statins in Prevention (JUPITER) trial, a randomised controlled trial evaluating the effect of rosuvastatin 20 mg daily versus placebo on the occurrence of cardiovascular events (myocardial infarction, stroke, arterial revascularisation, admission to hospital for unstable angina, or death from cardiovascular causes). Population 17,802 healthy men and women who had low density lipoprotein cholesterol levels of less than 3. 4 mmol/L and high sensitivity C reactive protein levels of 2. 0 mg/L or more V体育安卓版. .

Methods: Data from the Justification for the Use of Statins in Prevention trial were used to predict rosuvastatin treatment effect for individual patients based on existing risk scores (Framingham and Reynolds) and on a newly developed prediction model V体育ios版. We compared the net benefit of prediction based rosuvastatin treatment (selective treatment of patients whose predicted treatment effect exceeds a decision threshold) with the net benefit of treating either everyone or no one. .

Results: The median predicted 10 year absolute risk reduction for cardiovascular events was 4. 4% (interquartile range 2. 6-7. 0%) based on the Framingham risk score, 4. 2% (2. 5-7. 1%) based on the Reynolds score, and 3. 9% (2. 5-6. 1%) based on the newly developed model (optimal fit model). Prediction based treatment was associated with more net benefit than treating everyone or no one, provided that the decision threshold was between 2% and 7%, and thus that the number willing to treat (NWT) to prevent one cardiovascular event over 10 years was between 15 and 50. VSports最新版本.

Conclusions: Data from randomised trials can be used to predict treatment effect in terms of absolute risk reduction for individual patients, based on a newly developed model or, if available, existing risk scores. The value of such prediction of treatment effect for medical decision making is conditional on the NWT to prevent one outcome event V体育平台登录. Trial registration number Clinicaltrials. gov NCT00239681. .

PubMed Disclaimer

V体育安卓版 - Conflict of interest statement

Competing interests: All authors have completed the ICMJE uniform disclosure form at www. icmje. org/coi_disclosure. pdf (available on request from the corresponding author) and declare: PMR is the principal investigator of the investigator initiated Justification for the Use of Statins in Prevention trial, which was funded by AstraZeneca (Wilmington, Delaware). PMR received grant support from Novartis and Roche; consulting fees from Siemens Medical Systems, ISIS, and Vascular Biogenetics; and is listed as a co-inventor on patents held by the Brigham and Women’s Hospital that relate to the use of inflammatory biomarkers in cardiovascular disease that have been licensed to Siemens Medical Systems (Erlangen, Germany) and AstraZeneca. FLJV’s department receives grant support from Merck, the Netherlands Organisation for Health Research and Development, and the Catharijne Foundation Utrecht; and speaker fees from Merck and AstraZeneca. JAND, AMJW, NPP, EWS, YvdG, and NRC have no relationships with industry that might have an interest in the submitted work in the previous three years. All authors have no non-financial interests that may be relevant to the submitted work VSports注册入口.

Figures

None
Fig 1 Basic concept for weighing treatment effect against harm. Treatment effect usually increases with baseline risk, whereas harm is relatively constant for all patients. Those whose treatment effect exceeds treatment related harm (reflected by decision threshold) benefit from treatment
None
Fig 2 Calibration plots. Predicted and observed two year event free survival for cardiovascular events within 10ths of predicted survival using three models. P values derived from the Hosmer-Lemeshow test
None
Fig 3 Distribution of predicted 10 year absolute treatment effect (absolute risk reduction) based on Framingham risk score, Reynolds risk score, and optimal fit model, with coloured bars indicating predicted treatment effects for two different patient scenarios. JUPITER=the Justification for the Use of Statins in Prevention trial
None
Fig 4 Decision curve: graphical representation of net benefit. For large values of numbers willing to treat (NWT), the net benefit of treating all patients is about equal to the net benefit of prediction based treatment. The net benefit of treating all patients becomes negative if the NWT is less than 20, whereas the net benefit of prediction based treatment is still positive for a NWT of 20 and converges to zero for smaller values of NWT
None
Fig 5 Implications for clinical practice. Justification for the Use of Statins in Prevention trial shows that treatment of all patients is the strategy of choice if the 10 year number willing to treat (NWT) is 50 or more. Treating no one is preferable if the 10 year NWT is 15 or fewer. If the NWT is between 15 and 50, prediction based treatment results in most net benefit
See this image and copyright information in PMC

References

    1. Glasziou PP, Irwig LM. An evidence based approach to individualising treatment. BMJ 1995;311:1356-9. - PMC - PubMed
    1. Hayward RA, Kent DM, Vijan S, Hofer TP. Multivariable risk prediction can greatly enhance the statistical power of clinical trial subgroup analysis. BMC Med Res Methodol 2006;6:18. - V体育2025版 - PMC - PubMed
    1. Kent DM, Hayward RA. Limitations of applying summary results of clinical trials to individual patients: the need for risk stratification. JAMA 2007;298:1209-12. - PubMed
    1. Rothwell PM. Can overall results of clinical trials be applied to all patients? Lancet 1995;345:1616-9. - PubMed
    1. Vickers AJ, Kattan MW, Daniel S. Method for evaluating prediction models that apply the results of randomized trials to individual patients. Trials 2007;8:14. - PMC - PubMed

"V体育平台登录" Publication types

MeSH terms

"VSports在线直播" Substances