Dataset Information

Weighting components of composite end points in clinical trials: an approach using disability-adjusted life-years.

ABSTRACT: Conventional analysis of vascular prevention trials assigns equal weight to disparate vascular events in a composite end point at variance with the public's perception of their differential impact on health outcome. This study sought to apply the disability-adjusted life-year (DALY) metric to differential weighting individual vascular end points in trial analyses.DALY values for the most common major end points in vascular prevention trials (nonfatal myocardial infarction, nonfatal stroke, and vascular death), were derived by using World Health Organization Global Burden of Disease Project methodology. The standardized DALYs for each event were applied to recent major primary and secondary vascular prevention trials and to hypothetical model trials.Standardized DALYs lost were 7.63 for nonfatal stroke, 5.14 for nonfatal myocardial infarction, and 11.59 for vascular death. In the published trials analyses, the direction of treatment effects was consistent between DALY and standard event analysis, but the rank order of treatment effect changed for 10 of 18 trials. The DALY analysis also permitted derivation of number-needed-to-treat values to gain 1 DALY: 2.1 for anticoagulation in atrial fibrillation, 2.7 for carotid endarterectomy in symptomatic stenosis, and 4.7 for clopidogrel added to aspirin in acute coronary syndrome. Hypothetical trial analyses demonstrated that the DALY metric more finely discriminates treatment effects.Compared with a nonfatal myocardial infarction, a nonfatal stroke causes a 1.48-fold greater loss and vascular death a 2.25-fold greater loss of DALY. DALY analysis integrates these valuations in a summary metric reflecting the net impact of therapy on patient and societal health, complementing conventional end point analyses.

SUBMITTER: Hong KS

PROVIDER: S-EPMC3109505 | biostudies-literature | 2011 Jun

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Weighting components of composite end points in clinical trials: an approach using disability-adjusted life-years.

Hong Keun-Sik KS Ali Latisha K LK Selco Scott L SL Fonarow Gregg C GC Saver Jeffrey L JL

Stroke 20110428 6

<h4>Background and purpose</h4>Conventional analysis of vascular prevention trials assigns equal weight to disparate vascular events in a composite end point at variance with the public's perception of their differential impact on health outcome. This study sought to apply the disability-adjusted life-year (DALY) metric to differential weighting individual vascular end points in trial analyses.<h4>Methods</h4>DALY values for the most common major end points in vascular prevention trials (nonfata ...[more]

PMID: 21527766

Similar Datasets

Project description:ImportanceIntracerebral hemorrhage (ICH) contributes significantly to the global burden of disease.ObjectiveTo examine the association of ICH and secondary injury with disability-adjusted life-years (DALYs) for the individual patient.Design, setting, and participantsThis cohort study was conducted using data from the Universitätsklinikum Erlangen Cohort of Patients With Spontaneous Intracerebral Hemorrhage study. Consecutive patients admitted to a single tertiary care center from January 1, 2006, to December 31, 2015, were included. The sample comprised patients with oral anticoagulation-associated ICH (OAC-ICH) or primary spontaneous ICH (non-OAC-ICH). Statistical analysis was conducted from October 1 to December 31, 2020.ExposuresICH occurrence and secondary injury.Main outcomes and measuresDALYs, years of life lost (YLL), and years lived with disability (YLD) were analyzed by hematoma location, ICH volume, and secondary injury (ie, hematoma expansion [HE], intraventricular hemorrhage [IVH], and perihemorrhagic edema [PHE]).ResultsAmong 1322 patients with ICH, 615 (46.5%) were women and the mean (SD) age at hospital admission was 71 (13) years; ICH was associated with a mean (SD) of 9.46 (8.08) DALYs, 5.72 (8.29) YLL, and 3.74 (5.95) YLD. There were statistically significant differences in mean (SD) DALYs by extent of hematoma volume (< 10 mL ICH: 7.05 [6.79] DALYs; 10-30 mL ICH: 9.91 [8.35] DALYs; >30 mL ICH: 12.42 [8.47] DALYs; P < .001) and ICH location (deep location: 10.60 [8.35] DALYs; lobar location: 8.18 [7.63] DALYs; cerebellum: 8.14 [6.80] DALYs; brainstem: 12.63 [9.21] DALYs; P < .001). Regarding population-level disease burden of secondary injuries after ICH, there was a statistically significant difference in mean (SD) by injury type, with 0.94 (3.19) DALYs for HE, 2.45 (4.16) DALYs for IVH, and 1.96 (2.66) DALYs for PHE (P < .001) among the entire ICH cohort. Regarding individual-level exposure to secondary injuries after ICH, there were a mean (SD) 7.14 (6.62) DALYs for HE, 4.58 (4.75) DALYs for IVH, and 3.35 (3.28) DALYs for PHE among patients with ICH affected by secondary injuries.Conclusions and relevanceThese findings suggest that there is a high burden of disability associated with ICH and secondary injuries, and the findings may guide public health strategies. The study findings further suggest that IVH and PHE may be relevant for the overall outcome of patients with ICH, that DALYs may represent a viable outcome parameter for studies to evaluate treatment outcomes in ICH research, and that IVH and PHE may represent potential treatment targets.

Project description:BackgroundThe Chinese population has aged significantly in the last few decades. Comprehensive health losses including both fatal and non-fatal health outcomes associated with ageing in China have not been detailed.MethodsBased on freely accessible disability adjusted life years (DALYs) estimated by the Global Burden of Diseases (GBD) 2017, we adopted a robust decomposition method that ascribes changes in DALYs in any given country across two time points to changes resulting from three sources: population size, age structure, and age-specific DALYs rate per 100,000 population. Using the method, we calculated DALYs associated with population ageing in China from 1990 to 2017 and examined the counteraction between the effects of DALYs rate change and population ageing. This method extends previous work through attributing the change in DALYs to the three sources.ResultsPopulation ageing was associated with 92.8 million DALYs between 1990 and 2017 in China, of which 65.8% (61.1 million) were years of life lost (YLLs). Males had comparatively more DALYs associated with population ageing than females in the study period. The five leading causes of DALYs associated with population ageing between 1990 and 2017 were stroke (23.6 million), chronic obstructive pulmonary disease (COPD) (18.3 million), ischemic heart disease (13.0 million), tracheal, bronchus, and lung cancer (6.1 million) and liver cancer (5.0 million). Between 1990 and 2017, changes in DALYs associated with age-specific DALY rate reductions far exceeded those related to population ageing (- 196.2 million versus 92.8 million); 57.5% (- 112.8 million) of DALYs were caused by decreases in rates attributed to 84 modifiable risk factors.ConclusionPopulation ageing was associated with growing health loss in China from 1990 to 2017. Despite the recent progress in alleviating health loss associated with population ageing, the government should encourage scientific research on effective and affordable prevention and control strategies and should consider investment in resources to implement strategies nationwide to address the future challenge of population ageing.

Project description:BackgroundTo understand the magnitude and spatial-temporal distribution of the regional burden attributable to severe mental disorders is of great essential and high policy relevance. The study aimed to address the burden of severe mental disorders by evaluating the years of life lost, years lived with disability, and disability-adjusted life-years (DALYs) in Guangdong, China.MethodsWe undertook a longitudinal study based on a multicenter database established by the Health Commission of Guangdong, involving a total of 21 prefectures and four economic regions in the Guangdong province. A total of 520,731 medical records from patients with severe mental disorders were collected for 2010-2020. Data were analyzed via an integrated evaluation framework by synthesizing prevalence estimates, epidemiological adjustment as well as comorbidity assessment to develop internally consistent estimates of DALY. DALY changes during 2010-2020 were decomposed by population growth and aging and further grouped by Socio-demographic Index (SDI). DALYs were projected to 2030 by the weighted median annualized rate of change in 2010-2020.ResultsIn 2010-2020, the average DALYs for severe mental disorders reached 798,474 (95% uncertainty interval [UI]: 536,280-1,270,465) person-years (52.2% for males, and 47.8% for females). Severe mental disorders led to a great amount of disease burden, especially in Guangzhou, Shenzhen, and Foshan cities. Schizophrenia and mental retardation with mental disorders were the two leading sources of the burden ascribed to severe mental disorders. Population growth and aging could be accountable for the increasing burden of severe mental disorders. Economic regions with higher SDI carried a greater burden but had lower annualized rates of change in DALYs. The overall burden of severe mental disorders is projected to rise modestly over the next decade.ConclusionsThe findings urge prioritization of initiatives focused on public mental health, prevention strategies, health resources reallocation, and active involvement of authorities to effectively address the anticipated needs.

Dataset Information

Weighting components of composite end points in clinical trials: an approach using disability-adjusted life-years.

Publications

Weighting components of composite end points in clinical trials: an approach using disability-adjusted life-years.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets