title: Eligibility criteria for HIV clinical trials and generalizability of results: the gap between published reports and study protocols.
abstract: OBJECTIVE
  Applicability of randomized controlled clinical trial (RCT) results to 'real world' situations is dependent on the comparability of trial participants to general patient populations. A full disclosure of criteria employed for trial enrollment is necessary for clinicians to assess generalizability. We sought to assess both the impact on generalizability and the disclosure rate of enrollment criteria for 32 major HIV RCTs in the AIDS Clinical Trial Group (ACTG) and Community Programs for Clinical Research on AIDS (CPCRA) trial networks.
  
  
  METHODS
  Eligibility criteria were compared in complete protocols to criteria listed in publications from these 32 NIH-funded HIV RCTs. We then applied these criteria to the Women's Interagency HIV Study (WIHS), the largest cohort study of HIV-infected women in the US.
  
  
  RESULTS
  When applied to WIHS, eligibility criteria from protocols excluded 0-67.6% (median 42%) of WIHS participants (50.6% excluded from ACTG trials). Eligibility criteria in publications excluded 0-62% (median 19.6%) of WIHS (21.2% excluded from ACTG trials). The number of women in WIHS seemingly ineligible for trial participation per enrollment criteria listed in publications averaged only 60% of those actually excluded based on the protocols.
  
  
  CONCLUSIONS
  We found that HIV RCT eligibility criteria excluded a large proportion of a representative cohort of HIV-infected women from trial participation. Furthermore, trial publications are not fully reflective of protocols in terms of disclosing eligibility criteria. Standardization and full disclosure of trial methodology will allow clinicians and researchers to more fully assess the generalizability of findings to their patient populations.
authors.affiliation: Department of Medicine, University of California, San Francisco 94122, USA. monica.gandhi@ucsf.edu
authors.forename: Monica
authors.initials: M
authors.lastname: Gandhi
authors.forename: Niloufar
authors.initials: N
authors.lastname: Ameli
authors.forename: Peter
authors.initials: P
authors.lastname: Bacchetti
authors.forename: Gerald B
authors.initials: GB
authors.lastname: Sharp
authors.forename: Audrey L
authors.initials: AL
authors.lastname: French
authors.forename: Mary
authors.initials: M
authors.lastname: Young
authors.forename: Stephen J
authors.initials: SJ
authors.lastname: Gange
authors.forename: Kathryn
authors.initials: K
authors.lastname: Anastos
authors.forename: Susan
authors.initials: S
authors.lastname: Holman
authors.forename: Alexandra
authors.initials: A
authors.lastname: Levine
authors.forename: Ruth M
authors.initials: RM
authors.lastname: Greenblatt
mesh_terms: D002985:Clinical Protocols; D015331:Cohort Studies; D005260:Female; D015658:HIV Infections / Q000188:drug therapy*; D006801:Humans; D018579:Patient Selection; D016032:Randomized Controlled Trials as Topic / Q000379:methods*