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.
authors.affiliation: Department of Medicine, Division of Infectious Diseases, Massachusetts General Hospital, Boston, MA, USA.
authors.forename: V A
authors.initials: VA
authors.lastname: Triant
authors.forename: F
authors.initials: F
authors.lastname: Josephson
authors.forename: C G
authors.initials: CG
authors.lastname: Rochester
authors.forename: K N
authors.initials: KN
authors.lastname: Althoff
authors.forename: K
authors.initials: K
authors.lastname: Marcus
authors.forename: R
authors.initials: R
authors.lastname: Munk
authors.forename: C
authors.initials: C
authors.lastname: Cooper
authors.forename: R B
authors.initials: RB
authors.lastname: D'Agostino
authors.forename: D
authors.initials: D
authors.lastname: Costagliola
authors.forename: C A
authors.initials: CA
authors.lastname: Sabin
authors.forename: P L
authors.initials: PL
authors.lastname: Williams
authors.forename: S
authors.initials: S
authors.lastname: Hughes
authors.forename: W S
authors.initials: WS
authors.lastname: Post
authors.forename: N
authors.initials: N
authors.lastname: Chandra-Strobos
authors.forename: G
authors.initials: G
authors.lastname: Guaraldi
authors.forename: S S
authors.initials: SS
authors.lastname: Young
authors.forename: R
authors.initials: R
authors.lastname: Obenchain
authors.forename: R
authors.initials: R
authors.lastname: Bedimo
authors.forename: V
authors.initials: V
authors.lastname: Miller
authors.forename: J
authors.initials: J
authors.lastname: Strobos
mesh_terms: D019380:Anti-HIV Agents / Q000009:adverse effects*; D002318:Cardiovascular Diseases / Q000139:chemically induced* / Q000209:etiology; D003627:Data Interpretation, Statistical; D015658:HIV Infections / Q000150:complications / Q000188:drug therapy*; D006801:Humans; D008954:Models, Biological; D015233:Models, Statistical; D012107:Research Design; D012307:Risk Factors
chemical_list: D019380:Anti-HIV Agents
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