A Controlled, Randomized Double-Blind Study to Evaluate the Safety and Efficacy of Chitosan-N-Acetylcysteine for the Treatment of Dry Eye Syndrome.

PURPOSE: This study was designed to evaluate the effect of chitosan-N-acetylcysteine (C-NAC) eye drops on tear film thickness (TFT) in patients with dry eye syndrome (DES). METHODS: This was a controlled, randomized, double-blind clinical investigation with patients assigned to 2 cohorts. In Cohort I, 21 patients were randomized to receive 1 instillation of C-NAC eye drops in 1 eye and placebo (normal saline solution) in the contralateral eye. In Cohort II, 17 patients were randomized to receive C-NAC eye drops once (QD) or twice (BID) daily for 5 days. TFT was assessed with a custom-built ultrahigh-resolution optical coherence tomography system. RESULTS: In Cohort I, mean TFT increased from 3.9 ± 0.5 µm predose to 4.8 ± 1.1 µm 10 min postdose after treatment with C-NAC. The increase was significantly different from placebo over time (P < 0.0001) and remained stable until 24 h postdose. In Cohort II, TFT increased with QD and BID instillation, with no significant difference between regimens. In both groups, Ocular Surface Disease Index scores improved, fewer patients presented with corneal damage, and symptoms of ocular discomfort/conjunctival redness were reduced. CONCLUSIONS: A single instillation of C-NAC significantly increased mean TFT in patients with DES as early as 10 min after instillation and lasted for 24 h. The magnitude of the increase in TFT following a single instillation was comparable with that after instillation twice daily over 5 days. Corneal damage improved in >60% of patients. C-NAC could be a viable treatment option for DES.

Improving health status and reduction of institutionalization in long-term care--Effects of the Resident Assessment Instrument-Home Care by degree of implementation.

A cluster randomized controlled trial showed that the Resident Assessment Instrument (RAI) could not improve or stabilize the health status of people in need of long-term care or reduce the rate of institutionalization in Germany among clients of home care agencies. The aim of this article is to investigate whether the effect of RAI depends on the degree of implementation. A factor analysis was used to distinguish between those agencies that implemented RAI intensively and those that did not. The clients of home care agencies working intensively with RAI were significantly less hospitalized (P = 0.0284) and fared slightly better according to activities of daily living (ADL, instrumental ADL (IADL)), cognitive skills (Mini-Mental Status Test (MMST)) and quality of life (EuroQol (EQ-5D)) compared with the control group. In contrast, those not working intensively with RAI had worse outcomes (IADL, MMST, EQ-5D) than the control group (not significant). It is important to guarantee a successful implementation of RAI.

The long and bumpy road to outcome-oriented management of long-term care in Germany: implementation of the Resident Assessment Instrument in home-care services.

OBJECTIVE: Although the quality of long-term care has improved, many problems still remain, and better processes seem to be necessary. Hence, outcome-oriented management is of particular importance. The Resident Assessment Instrument (RAI) is a tool that has been used successfully in many countries to improve quality of care. However, there are problems of implementation and it lacks information on the conditions of successful or failing information of the RAI. The aim of this article is to find out to what extent technical/qualification requirements help to introduce or lead to failure of the implementation of an assessment instrument like RAI. METHODS: Therefore, a cluster randomized controlled trial showed services using RAI intensively tend to have better outcomes after 12 months. But the effects depend on the success of the implementation. Using a factor analysis, an index was built to divide the care providers into "optimal" and "suboptimal" RAI users. RESULTS: Some factors that seem to lead to a rather successful implementation could be detected: A higher proportion of qualified staff, a lower perceived quantitative workload, a small size of care providers, the type of ownership (for-profit) and a late entry in study [Correction made here after initial online publication.]. CONCLUSION: The success or failure of the implementation of an outcome-oriented control instrument is determined by professional, organizational restrictions. The results show that a better implementation leads to better outcomes for clients.