Number of tables: 3 Number of figures: 3 Number of references: 38 Word count: 2936 Background Delirium is a common debilitating complication of advanced cancer. ObjectiveTo determine if a multicomponent non-pharmacological delirium prevention intervention was feasible for adult patients with advanced cancer, prior to a phase III (efficacy) trial. DesignPhase II (feasibility) cluster randomized controlled trial. All sites implemented delirium screening and diagnostic assessment. Strategies within sleep, vision and hearing, hydration, orientation, mobility and family domains were delivered to enrolled patients at intervention sites admission days 1-7.Control sites then implemented the intervention ('waitlist sites'). SettingFour Australian palliative care units MeasurementsThe primary outcome was adherence, with an a priori endpoint of at least 60% patients achieving full adherence. Secondary outcomes were interdisciplinary care delivery, delirium measures and adverse events, analyzed descriptively and inferentially. ResultsSixty-five enrolled patients (25 control, 20 intervention, 20 waitlist) had 98% delirium screens and 75% diagnostic assessments completed. Nurses (67%), physicians (16%), allied health (8.4%), family (7%), patients (1%) and volunteers (0.5%) delivered the intervention. There was full adherence for 5% patients at intervention sites, partial for 25%. Both full and partial adherence was higher at waitlist sites: 25% and 45%, respectively. One-third of control site patients (32%) became delirious within seven days of admission compared to one-fifth (20%) at both intervention and waitlist sites (p=0.5). Mean (SD) Delirium Rating Scale-Revised-1998 scores were 16.8 +12.0 control sites versus 18.4 +8.2 (p=0.6) intervention and 18.7 +7.8 (p=0.5) waitlist sites. The intervention caused no adverse events. ConclusionThe intervention requires modification for optimal adherence in a phase III trial.

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Age-related cataract is reported to be associated with increased risk of death. The authors investigated the association of presence and type of cataract with mortality in the participants of the Italian-American Case-Control Cataract Study (Parma, Italy, 1987-1989), which included 1,008 persons aged 45-79 years who had age-related cataract and 469 who had clear lenses. Slit-lamp and retroillumination lens photographs were taken at baseline and graded with the Lens Opacities Classification System II. During 10 years of follow-up (range, 8.9-11.8 years; 11,318 person-years), the authors collected information on 1,429 participants and documented 339 deaths. After adjustment for age, sex, and other mortality risk factors, mixed cataracts with a nuclear/posterior subcapsular component were significantly associated with higher risk of death by Cox proportional hazards regression analyses. Hazard ratios were 2.26 (95% confidence interval (CI): 1.07, 4.76) for nuclear/posterior subcapsular and 1.62 (95% CI: 1.01, 2.61) for cortical/nuclear/posterior subcapsular opacities. In multivariate analysis, mixed types of opacity (any) were associated with increased mortality for malignancy (hazard ratio = 1.81, 95% CI: 1.04, 3.15) and "other" causes (hazard ratio = 2.29, 95% CI: 1.07, 4.92). These findings are compatible with the hypothesis that mixed types of cataract with a nuclear/posterior subcapsular component are indicators of accelerated aging.

BackgroundThe 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.MethodsTrial 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.Results610 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.ConclusionsThe 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.

The AREDS lens opacities grading system appears to be sufficiently reliable to detect changes of at least 10% areal involvement for cortical, 15% areal involvement for posterior subcapsular, and 1.0 units for nuclear opacities. It therefore seems sufficiently sensitive to adequately monitor progression of lens opacities in a longitudinal study of patients with early cataract. Its applicability in a population with advanced or complex mixed opacities must await further testing.