title: A post-trial survey to assess the impact of dissemination of results and unmasking on participants in a 13-year randomised controlled trial on age-related cataract.
abstract: BACKGROUND
  The Italian-American Clinical Trial of Nutritional Supplements and Age-Related Cataract was designed to assess the impact of a multivitamin-mineral supplement on age-related cataract. Trial results showed evidence of a beneficial effect of the supplement on all types of cataract combined, opposite effects on two of the three types of cataract (beneficial for nuclear opacities and harmful for posterior sub-capsular opacities) and no statistically significant effect on cortical opacities. No treatment recommendations were made. A post-trial survey was conducted on 817 surviving elderly participants to assess their satisfaction, their understanding of treatment assignment to supplement or placebo and the success of masking.
  
  
  METHODS
  Trial results were communicated by letter and the level of satisfaction and of understanding of the results was assessed by a questionnaire. Participants were offered the option of being unmasked: a second questionnaire was administered to this subset to assess their understanding of the randomisation process and the success of masking.
  
  
  RESULTS
  610 participants (74.7%) responded to the survey:94.6% thought the description of the results was "very clear" or "quite clear", 5.4% "not clear" or "do not know"; 89.8% considered the results "very interesting" or "quite interesting", 10.2% "not interesting" or "do not know"; 60.3% expressed "satisfaction", 17.2% "both satisfaction and concern", 2.6% "concern", 19.9% "indifference" or "do not know".480 participants (78.7%) accepted the offer to be unmasked to their treatment assignment: 395 (82.3%) recalled/understood the possibility of assignment to vitamins or placebo, 85 (17.7%) did not. 68 participants (17.2%) thought they had taken vitamins (79.4% were correct; p = 0.0006), 47 (11.9%) thought they had taken placebo (59.6% were correct; p = 0.46) and 280 (70.9%) declared they did not know.
  
  
  CONCLUSIONS
  The results were made difficult to explain to study participants by the qualitatively different effect of treatment on the two most visually significant types of cataract. Although the study did not lead to a recommendation to use the dietary supplement, the vast majority of participants reported satisfaction after they received the results but almost 20% of the participants expressed some concern. Masking to treatment assignment was successful in the majority of participants.
authors.affiliation: Sezione di Oftalmologia, Università degli Studi di Parma, Via Gramsci 14, 43126 Parma, Italy. sallylouise.williams@unipr.it
authors.forename: Sally L
authors.initials: SL
authors.lastname: Williams
authors.forename: Luigina
authors.initials: L
authors.lastname: Ferrigno
authors.forename: Giovanni
authors.initials: G
authors.lastname: Maraini
authors.forename: Francesco
authors.initials: F
authors.lastname: Rosmini
authors.forename: Robert D
authors.initials: RD
authors.lastname: Sperduto
mesh_terms: D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D000375:Aging; D002386:Cataract / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D016009:Chi-Square Distribution; D032882:Comprehension; D015709:Correspondence as Topic; D019587:Dietary Supplements / Q000009:adverse effects; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D033181:Information Dissemination; D008297:Male; D008875:Middle Aged; D008903:Minerals / Q000009:adverse effects / Q000627:therapeutic use*; D017060:Patient Satisfaction; D012107:Research Design; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D014815:Vitamins / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D004338:Drug Combinations; D008903:Minerals; D014815:Vitamins