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


BMJ 2011; 343:d5888 doi: 10.1136/bmj.d5888 (Published 3 October 2011)

Cite this as: BMJ 2011; 343:d5888

  • Research

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

Free via Creative Commons: OPEN ACCESS

  1. Johannes A N Dorresteijn, epidemiologist and medical doctor1,
  2. Frank L J Visseren, professor of vascular medicine, epidemiologist, and internist1
  3. Paul M Ridker, Eugene Braunwald professor of medicine, epidemiologist, and cardiologist2
  4. Annemarie M J Wassink, internist and postdoctoral researcher1
  5. Nina P Paynter, assistant professor of epidemiology2
  6. Ewout W Steyerberg, professor of medical decision making, and methodologist3
  7. Yolanda van der Graaf, professor of epidemiology and imaging4
  8. Nancy R Cook, associate professor of biostatistics and epidemiology2
Author Affiliations

  1. 1Department of Vascular Medicine, University Medical Center Utrecht, PO Box 85500, 3508 GA Utrecht, Netherlands


  2. 2Division of Preventive Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, USA


  3. 3Department of Public Health, Erasmus Medical Center, Rotterdam, Netherlands


  4. 4Julius Center for Health Sciences and Primary Care, Utrecht, Netherlands

  1. Correspondence to: F L J Visseren F.L.J.Visseren@umcutrecht.nl
  • Accepted 12 August 2011

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.
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.
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. 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.
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.
Trial registration number Clinicaltrials.gov NCT00239681.

Country profiles on noncommunicable disease trends in 193 countries


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WHO maps noncommunicable disease trends in all countries

Country profiles on noncommunicable disease trends in 193 countries

News release
 A new WHO report features information about the noncommunicable diseases (NCDs) situation in 193 countries, as global leaders prepare to meet at the United Nations high-level meeting on noncommunicable diseases in New York, 19-20 September 2011.
“This report indicates where each government needs to focus to prevent and treat the four major killers: cancer, heart disease and stroke, lung disease and diabetes,” says Dr Ala Alwan, Assistant Director-General for Noncommunicable Diseases and Mental Health at WHO.
The report includes details of what proportion of each country’s deaths are due to noncommunicable diseases. Using graphs in a page per country presentation format, the report provides information on prevalence, trends in metabolic risk factors (cholesterol, blood pressure, body mass index and blood sugar) alongside data on the country’s capacity to tackle the diseases.
Noncommunicable diseases are the top cause of death worldwide, killing more than 36 million people in 2008. Cardiovascular diseases were responsible for 48% of these deaths, cancers 21%, chronic respiratory diseases 12%, and diabetes 3%.

“Premature” deaths

In 2008, more than nine million of all deaths attributed to NCDs occurred before the age of 60; 90% of these “premature” deaths occurred in low- and middle-income countries. One of the findings shows that men and women in low-income countries are around three times more likely to die of NCDs before the age of sixty than in high-income countries.
According to these estimates, the proportion of men dying under the age of 60 from NCDs can be as high as 67%. Among women under 60, the highest proportion was 58%.
The lowest rates of mortality from noncommunicable diseases for men under 60 were 8% and for women under 60 it was 6%.

Risk factors

The profiles report on the proportion of people who smoke and are physically inactive. They also indicate trends for four factors that increase people’s risk of developing these diseases, blood pressure, cholesterol, body mass index and blood sugar over the past 30 years.
In the United States of America, for example, 87% of all deaths are due to noncommunicable diseases. 16% of the population smokes and 43% are physically inactive. On average, blood pressure has decreased since 1980; body mass index has increased; and glucose levels have risen.
Overall, the trends indicate that in many high income countries, action to reduce blood pressure and cholesterol is having an impact, but there is a need to do more on body mass index and managing diabetes.

Countries’ capacity to prevent and treat noncommunicable diseases

The profiles show what countries are doing to tackle noncommunicable diseases in terms of institutional capacity, specified funding, and actions to address the four main diseases and their associated risk factors.
The report also highlights what all countries need to do to reduce people’s exposure to risk factors and improve services to prevent and treat noncommunicable diseases.

UN high-level meeting on noncommunicable diseases

The UN meeting will highlight the importance of setting targets for progress. This report provides all countries with a baseline for monitoring epidemiological trends and assessing the progress they are making to address noncommunicable diseases. The WHO plans to issue an updated report in 2013.

For more information, please contact:

Gregory Hartl
Communications Officer
WHO, Geneva
Telephone:             +41 22 791 4458      
E-mail: hartlg@who.int

Saúde urbana, ambiente e desigualdades


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AZAMBUJA, M., ACHUTTI, A., REIS, R., SILVA, J., FISHER, P., ROSA, R., BORDIN, R., OLIVEIRA, F., CELESTE, R., SCHNEIDER, A., CAMPANI, D., PICCININI, L., RAMOS, M., SATTLER, M., OLIVEIRA, P., LEWGOY, A.. Saúde urbana, ambiente e desigualdades. Revista Brasileira de Medicina de Família e Comunidade, Local de publicação (editar no plugin de tradução o arquivo da citação ABNT), 6, abr. 2011. Disponível em: <http://www.rbmfc.org.br/index.php/rbmfc/article/view/151>. Acesso em: 23 Set. 2011..

Saúde urbana, ambiente e desigualdades

Maria Inês Reinert Azambuja, Aloyzio Cechella Achutti, Roberta Alvarenga Reis, Jacqueline Oliveira Silva, Paul Douglas Fisher, Roger dos Santos Rosa, Ronaldo Bordin, Francisco Arsego de Oliveira, Roger Keller Celeste, Aline Petter Schneider, Darci Barnech Campani, Lívia Piccinini, Maurem Ramos, Miguel Aloysio Sattler, Paulo Antonio Barros Oliveira, Alzira Maria Baptista Lewgoy

Resumo

Os ambientes psicossocial, econômico e físico, nos quais se nasce, cresce, vive e trabalha, afetam a saúde e a longevidade, tanto quanto o fumo, o exercício e a dieta. A atenção individual à saúde não é suficiente para prevenir ou controlar os efeitos das más condições ambientais. Evidências históricas e atuais apontam para o agravamento das condições de saúde das populações mais pobres, acompanhando processos de urbanização rápida. Esperadamente, o envelhecimento populacional num ambiente urbano de desigualdade social deverá agravar a situação de saúde da população mais pobre, resultando em mais sofrimento e em perdas econômicas para o país. Com base nestas justificativas, um grupo de professores da Universidade Federal do Rio Grande do Sul se organizou, via extensão universitária, para contribuir com a discussão e as iniciativas nacionais de intervenção sobre a saúde urbana. Os projetos do grupo abarcam: o debate sobre o impacto potencial de iniciativas privadas e políticas públicas setoriais (de habitação, saneamento, transporte, educação, inovação tecnológica, sustentabilidade ambiental etc.) na saúde urbana; a produção e divulgação de conteúdos sobre determinantes sociais e ambientais da saúde; a produção e disseminação dos indicadores de desigualdade social dos determinantes da saúde; a formação de recursos humanos; e a participação em redes sociais. A apresentação pública deste projeto cumpre o objetivo de contribuir desde já com essa discussão.

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