@article{f131e1ac057a4feea34e3a684437db37,
title = "Adverse outcome analyses of observational data: Assessing cardiovascular risk in HIV disease",
abstract = "Clinical decisions are ideally based on randomized trials but must often rely on observational data analyses, which are less straightforward and more influenced by methodology. The authors, from a series of expert roundtables convened by the Forum for Collaborative HIV Research on the use of observational studies to assess cardiovascular disease risk in human immunodeficiency virus infection, recommend that clinicians who review or interpret epidemiological publications consider 7 key statistical issues: (1) clear explanation of confounding and adjustment; (2) handling and impact of missing data; (3) consistency and clinical relevance of outcome measurements and covariate risk factors; (4) multivariate modeling techniques including time-dependent variables; (5) how multiple testing is addressed; (6) distinction between statistical and clinical significance; and (7) need for confirmation from independent databases. Recommendations to permit better understanding of potential methodological limitations include both responsible public access to de-identified source data, where permitted, and exploration of novel statistical methods.",
author = "Triant, {V. A.} and F. Josephson and Rochester, {C. G.} and Althoff, {K. N.} and K. Marcus and R. Munk and C. Cooper and D'Agostino, {R. B.} and D. Costagliola and Sabin, {C. A.} and Williams, {P. L.} and S. Hughes and Post, {W. S.} and N. Chandra-Strobos and G. Guaraldi and Young, {S. S.} and R. Obenchain and R. Bedimo and V. Miller and J. Strobos",
note = "Funding Information: Financial support. Support for the series of expert roundtable discussions, at which the need for this article was identified, was graciously provided by the Forum for Collaborative HIV Research, the HAART Oversight Committee, Gilead Sciences, Abbott Laboratories, ViiV Healthcare, and Tibotec Therapeutics. The Forum{\textquoteright}s HIV activities are supported by the Bill and Melinda Gates Foundation, AmfAR, the National Institutes of Health, the Centers for Disease Control and Prevention, Gilead Sciences, Abbott Laboratories, ViiV Healthcare, Bristol-Myers Squibb, BD Bio- sciences, bioM{\'e}rieux, Boehringer Ingelheim Pharmaceuticals, Idenix Pharmaceuticals, Merck Research Laboratories, Monogram Biosciences, Roche Molecular Diagnostics, EMD Serono, and Centocor Ortho Biotech. Funding Information: Potential conflicts of interest. R. B. receives financial support to provide scientific advice to Merck and Co, Tibotec Therapeutics, Gilead Sciences, EMD Serono, and Abbott and receives research funding from Merck & Co. D. C. receives financial support to provide scientific advice to, and receives grants from, Abbott, Boehringer-Ingelheim, Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline, Janssen-Cilag, Merck Sharp & Dohme-Chibret, and Roche Pharmaceuticals. S. H. is an employee of GlaxoSmithKline and holds stock options in GlaxoSmithKline. C. A. S. receives financial support for providing scientific advice to Janssen Pharmaceuticals, ViiV Healthcare, Gilead Sciences, and Bristol-Myers Squibb. V. A. T. and K. N. A. are supported by National Institutes of Health grants. C. G. R., K. M., and C. C. are employees of the US government. The views expressed in this article are their individual views and not those of the US government. F. J. is an employee of the Swedish Medical Products Agency (MPA). The views expressed in this article are his individual views, not those of the MPA. J. S. and V. M. are employees of the Forum for Collaborative HIV Research, an administrative unit in the School of Public Health of the University of California, Berkeley. All other authors report no potential conflicts of interest.",
year = "2012",
month = feb,
day = "1",
doi = "10.1093/cid/cir829",
language = "English (US)",
volume = "54",
pages = "408--413",
journal = "Clinical Infectious Diseases",
issn = "1058-4838",
publisher = "Oxford University Press",
number = "3",
}