Biocidal Efficacy of a Hydrogen Peroxide Lens Care Solution Incorporating a Novel Wetting Agent.

PURPOSE: To compare the antimicrobial effects of CLEAR CARE, a 3% hydrogen peroxide (H2O2) solution formulated for simultaneous cleaning, daily protein removal, disinfection, and storage of soft (hydrophilic) hydrogel, silicone hydrogel, and gas-permeable contact lenses, and CLEAR CARE PLUS, consisting of the 3% H2O2 solution plus a novel wetting agent, polyoxyethylene-polyoxybutylene (EOBO-21). METHODS: Three lots each of the 2 solutions were incubated with 5 compendial microorganisms required by the Food and Drug Administration (FDA) 510(k) and International Organization for Standardization (ISO) 14729 stand-alone procedures, 4 clinical isolates of Gram-positive and Gram-negative bacteria, and trophozoites and cysts of 2 Acanthamoeba strains that are associated with microbial keratitis. Microbial loads were evaluated after disinfection and neutralization. RESULTS: Both solutions exceeded the FDA/ISO stand-alone primary criteria against Gram-positive and Gram-negative compendial bacteria, yeast, and mold after only 1.5-hr disinfection/neutralization. At the recommended minimum disinfection time, bacteria were reduced by 4.4 to 5.1 logs, yeast by 4.4 to 4.9 logs, and mold by 2.9 to 3.5 logs with and without organic soil. In addition, both solutions eliminated or effectively reduced populations of clinically relevant ocular bacterial isolates (4.5-5.0 logs), Acanthamoeba trophozoites (3.4-4.2 logs), and cysts (1.5-2.1 logs). CONCLUSION: Both solutions eliminated or reduced populations of FDA/ISO compendial bacteria and fungi as well as clinically relevant microorganisms and Acanthamoeba trophozoites and cysts. The addition of EOBO-21 to the 3% H2O2 lens care solution had no impact on antimicrobial activity.

Diaphragm Activation in Ventilated Patients Using a Novel Transvenous Phrenic Nerve Pacing Catheter.

OBJECTIVES: Over 30% of critically ill patients on positive-pressure mechanical ventilation have difficulty weaning from the ventilator, many of whom acquire ventilator-induced diaphragm dysfunction. Temporary transvenous phrenic nerve pacing using a novel electrode-bearing catheter may provide a means to prevent diaphragm atrophy, to strengthen an atrophied diaphragm, and mitigate the harms of mechanical ventilation. We tested the initial safety, feasibility, and impact on ventilation of this novel approach. DESIGN: First-in-Humans case series. SETTING: Angiogram suite. PATIENTS: Twenty-four sedated, mechanically ventilated patients immediately prior to an elective atrial septal defect repair procedure. INTERVENTIONS: A 9.5-Fr central venous catheter with 19 embedded electrodes was placed via Seldinger technique into the left subclavian vein and superior vena cava and evaluated for up to 90 minutes. The electrode combinations determined to provide best transvenous stimulation of the right and left phrenic nerves were activated in synchrony with mechanically ventilated breaths. MEASUREMENTS AND MAIN RESULTS: One patient could not be tested for reasons unrelated to the device. In the 23 patients who underwent the full protocol, transvenous stimulation activated the diaphragm in 22 of 23 (96%) left phrenic capture attempts and 20 of 23 (87%) right phrenic capture attempts. In one subject, a congenital left-sided superior vena cava precluded right-sided capture. Significant reductions in ventilator pressure-time-product were achieved during stimulation assisted breaths in all 22 paced subjects (range, 9.9-48.6%; p < 0.001). There were no adverse events either immediately or at 2-week follow-up. CONCLUSIONS: In this First-in-Human series, diaphragm pacing with a temporary catheter was safe and effectively contributed to ventilation in conjunction with a mechanical ventilator.

Health literacy, associated lifestyle and demographic factors in adult population of an English city: a cross-sectional survey.

BACKGROUND: Lower health literacy is a public health issue that follows a social gradient, potentially reinforcing existing health inequalities. However, levels of health literacy in particular populations can be unclear and are a key to identifying effective public health interventions. This research examined health literacy levels in Stoke-on-Trent, where 31.2% of the population live in areas classified amongst the 10% most deprived in England. METHODS: A cross-sectional survey using the Newest Vital Sign examined associations with demographic factors, lifestyle behaviours, Internet use and self-rated health. The sample (n = 1046) took account of variance in levels of health literacy by age, educational attainment and deprivation. Bivariate logistic regression and multivariate logistic regression were used to estimate associations with health literacy when adjusted for other demographic factors and lifestyle behaviours. RESULTS: Nine hundred and seventy-two respondents completed the health literacy measure (93%): 277 (28.5%) scored low, 228 (23.5%) scored marginal and 467 (48.0%) scored adequate. Associations with higher rates of limited health literacy included older age, lower educational level, lower income, perceived poor health and lack of access to the Internet. CONCLUSIONS: Given the complexity of factors influencing health literacy interdisciplinary approaches across health and social care and the voluntary sector are essential in identifying and developing appropriate interventions.

Sleep-disordered breathing in heart failure: identifying and treating an important but often unrecognized comorbidity in heart failure patients.

Sleep-disordered breathing (SDB) is the most common comorbidity in patients with heart failure (HF) and has a significant impact on quality of life, morbidity, and mortality. A number of therapeutic options have become available in recent years that can improve quality of life and potentially the outcomes of HF patients with SDB. Unfortunately, SDB is not part of the routine evaluation and management of HF, so it remains untreated in most HF patients. Although recognition of the role of SDB in HF is increasing, clinical guidelines for the management of SDB in HF patients continue to be absent. This article provides an overview of SDB in HF and proposes a clinical care pathway to help clinicians to better recognize and treat SDB in their HF patients.

Efficacy of a Smartphone App Intervention for Reducing Caregiver Stress: Randomized Controlled Trial.

BACKGROUND: Caregivers play a pivotal role in maintaining an economically viable health care system, yet they are characterized by low levels of psychological well-being and consistently report unmet needs for psychological support. Mobile app-based (mobile health [mHealth]) interventions present a novel approach to both reducing stress and improving well-being. OBJECTIVE: This study aims to evaluate the effectiveness of a self-guided mobile app-based psychological intervention for people providing care to family or friends with a physical or mental disability. METHODS: In a randomized, single-blind, controlled trial, 183 caregivers recruited through the web were randomly allocated to either an intervention (n=73) or active control (n=110) condition. The intervention app contained treatment modules combining daily self-monitoring with third-wave (mindfulness-based) cognitive-behavioral therapies, whereas the active control app contained only self-monitoring features. Both programs were completed over a 5-week period. It was hypothesized that intervention app exposure would be associated with decreases in depression, anxiety, and stress, and increases in well-being, self-esteem, optimism, primary and secondary control, and social support. Outcomes were assessed at baseline, postintervention, and 3-4 months postintervention. App quality was also assessed. RESULTS: In total, 25% (18/73) of the intervention participants were lost to follow-up at 3 months, and 30.9% (34/110) of the participants from the wait-list control group dropped out before the postintervention survey. The intervention group experienced reductions in stress (b=-2.07; P=.04) and depressive symptoms (b=-1.36; P=.05) from baseline to postintervention. These changes were further enhanced from postintervention to follow-up, with the intervention group continuing to report lower levels of depression (b=-1.82; P=.03) and higher levels of emotional well-being (b=6.13; P<.001), optimism (b=0.78; P=.007), self-esteem (b=-0.84; P=.005), support from family (b=2.15; P=.001), support from significant others (b=2.66; P<.001), and subjective well-being (b=4.82; P<.001). On average, participants completed 2.5 (SD 1.05) out of 5 treatment modules. The overall quality of the app was also rated highly, with a mean score of 3.94 out of a maximum score of 5 (SD 0.58). CONCLUSIONS: This study demonstrates that mHealth psychological interventions are an effective treatment option for caregivers experiencing high levels of stress. Recommendations for improving mHealth interventions for caregivers include offering flexibility and customization in the treatment design. TRIAL REGISTRATION: Australian New Zealand Clinical Trial Registry ACTRN12616000996460; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=371170.

Temporary transvenous diaphragm pacing vs. standard of care for weaning from mechanical ventilation: study protocol for a randomized trial.

BACKGROUND: Mechanical ventilation (MV) is a life-saving technology that restores or assists breathing. Like any treatment, MV has side effects. In some patients it can cause diaphragmatic atrophy, injury, and dysfunction (ventilator-induced diaphragmatic dysfunction, VIDD). Accumulating evidence suggests that VIDD makes weaning from MV difficult, which involves increased morbidity and mortality. METHODS AND ANALYSIS: This paper describes the protocol of a randomized, controlled, open-label, multicenter trial that is designed to investigate the safety and effectiveness of a novel therapy, temporary transvenous diaphragm pacing (TTVDP), to improve weaning from MV in up to 88 mechanically ventilated adult patients who have failed at least two spontaneous breathing trials over at least 7 days. Patients will be randomized (1:1) to TTVDP (treatment) or standard of care (control) groups. The primary efficacy endpoint is time to successful extubation with no reintubation within 48 h. Secondary endpoints include maximal inspiratory pressure and ultrasound-measured changes in diaphragm thickness and diaphragm thickening fraction over time. In addition, observational data will be collected and analyzed, including 30-day mortality and time to discharge from the intensive care unit and from the hospital. The hypothesis to be tested postulates that more TTVDP patients than control patients will be successfully weaned from MV within the 30 days following randomization. DISCUSSION: This study is the first large-scale clinical trial of a novel technology (TTVDP) aimed at accelerating difficult weaning from MV. The technology tested provides the first therapy directed specifically at VIDD, an important cause of delayed weaning from MV. Its results will help delineate the place of this therapeutic approach in clinical practice and help design future studies aimed at defining the indications and benefits of TTVDP. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03096639 . Registered on 30 March 2017.

Comparison of patient recall of hormone therapy with physician records.

OBJECTIVE: The objective of this study was to compare patient recall of menopausal hormone therapy, obtained by personal interview, with that recorded in physicians' records. DESIGN: Data were from a case-control study of women aged 55 to 64 years at diagnosis of breast cancer in Los Angeles County, CA, between 1987 and 1989. Medical record information on 1,115 women reporting hormone therapy use (652 case patients and 463 control participants) was sought from 2,734 physicians and obtained from 1,350. Physician records for an additional 126 case patients and 90 control participants not reporting hormone therapy but reporting oral contraceptive use or benign breast disease were also obtained. RESULTS: Agreement between interview and physician records was 85% (kappa=0.59) for ever/never use of estrogen and 84% (kappa=0.59) for progestogen. The correlations for months of use were 0.43 and 0.34, respectively. For both drugs participants tended to report longer use, primarily because they reported earlier starting ages. Older and unmarried women recalled more unconfirmed estrogen use, whereas naturally menopausal women were more likely to report no estrogen use when the medical record was positive. We found no evidence of preferential recall bias by case patients. CONCLUSIONS: Interviews provide a moderately reliable measure for ever use of postmenopausal estrogen and progestogen. Recalled details are less reliable and may be affected by age, type of menopause, and recall interval.

Delayed high school start times later than 8:30am and impact on graduation rates and attendance rates.

OBJECTIVES: The first purpose of this study was to investigate changes in high school graduation rates with a delayed school start time of later than 8:30am. The second aim of the study was to analyze the association between a delayed high school start time later than 8:30am and attendance rates. DESIGN: In the current study, a pre-post design using a repeated-measures analysis of variance was used to examine changes in attendance and graduation rates 2 years after a delayed start was implemented. SETTING: Public high schools from 8 school districts (n=29 high schools) located throughout 7 different states. Schools were identified using previous research from the Children's National Medical Center's Division of Sleep Medicine Research Team. PARTICIPANTS AND MEASUREMENTS: A total membership of more than 30,000 high school students enrolled in the 29 schools identified by the Children's National Medical Center's Research Team. A pre-post design was used for a within-subject design, controlling for any school-to-school difference in the calculation of the response variable. This is the recommended technique for a study that may include data with potential measurement error. RESULTS: Findings from this study linked a start time of later than 8:30am to improved attendance rates and graduation rates. CONCLUSIONS: Attendance rates and graduation rates significantly improved in schools with delayed start times of 8:30am or later. School officials need to take special notice that this investigation also raises questions about whether later start times are a mechanism for closing the achievement gap due to improved graduation rates.

Using dynamic factor analysis to provide insights into data reliability in experience sampling studies.

The past 2 decades have seen increasing use of experience sampling methods (ESMs) to gain insights into the daily experience of affective states (e.g., its variability, as well as antecedents and consequences of temporary shifts in affect). Much less attention has been given to methodological challenges, such as how to ensure reliability of test scores obtained using ESM. The present study demonstrates the use of dynamic factor analysis (DFA) to quantify reliability of test scores in ESM contexts, evaluates the potential impact of unreliable test scores, and seeks to identify characteristics of individuals that may account for their unreliable test scores. One hundred twenty-seven participants completed baseline measures (demographics and personality traits), followed by a 7-day ESM phase in which positive and negative state affect were measured up to 6 times per day. Analyses showed that although at the sample level, scores on these affect measures exhibited adequate levels of reliability, up to one third of participants failed to meet conventional standards of reliability. Where these low reliability estimates were not significantly associated with personality factors, they could-in some cases-be explained by model misspecification where a meaningful alternative structure was available. Despite these potential differences in factor structure across participants, subsequent modeling with and without these "unreliable" cases showed similar substantive results. Hence, the present findings suggest typical analyses based on ESM data may be robust to individual differences in data structure and/or quality. Ways to augment the DFA approach to better understand unreliable cases are discussed. (PsycINFO Database Record

Immunocytochemical localization of atrial natriuretic peptide, vessel dilator, long-acting natriuretic peptide, and kaliuretic peptide in human pancreatic adenocarcinomas.

We recently found that four peptide hormones synthesized by the same gene completely inhibit the growth of human pancreatic adenocarcinomas in athymic mice. The present immunocytochemical investigation was designed to determine where in the adenocarcinomas these peptide hormones localize. Atrial natriuretic peptide, vessel dilator, long-acting natriuretic peptide, and kaliuretic peptide localized to the cytoplasm and nucleus of the human pancreatic adenocarcinomas, which is consistent with their ability to decrease DNA synthesis in the nucleus of this cancer. In this first investigation of where these peptide hormones with anticancer effects localize in any cancer, these peptide hormones also localized to the endothelium of capillaries and fibroblasts within these cancers. This is the first demonstration of growth-inhibiting peptide hormones localizing to the nucleus, where they inhibit DNA synthesis and may interact with growth-promoting hormones that localize there as the etiology of their ability to inhibit the growth of adenocarcinomas both in vitro and in vivo.

Validation of multi-stage telephone-based identification of cognitive impairment and dementia.

BACKGROUND: Many types of research on dementia and cognitive impairment require large sample sizes. Detailed in-person assessment using batteries of neuropyschologic testing is expensive. This study evaluates whether a brief telephone cognitive assessment strategy can reliably classify cognitive status when compared to an in-person "gold-standard" clinical assessment. METHODS: The gold standard assessment of cognitive status was conducted at the University of Southern California Alzheimer Disease Research Center (USC ADRC). It involved an examination of patients with a memory complaint by a neurologist or psychiatrist specializing in cognitive disorders and administration of a battery of neuropsychologic tests. The method being evaluated was a multi-staged assessment using the Telephone Interview of Cognitive Status-modified (TICSm) with patients and the Telephone Dementia Questionnaire (TDQ) with a proxy. Elderly male and female patients who had received the gold standard in-person assessment were asked to also undergo the telephone assessment. The unweighted kappa statistic was calculated to compare the gold standard and the multistage telephone assessment methods. Sensitivity for classification with dementia and specificity for classification as normal were also calculated. RESULTS: Of 50 patients who underwent the gold standard assessment and were referred for telephone assessment, 38 (76%) completed the TICS. The mean age was 78.1 years and 26 (68%) were female. When comparing the gold standard assessment and the telephone method for classifying subjects as having dementia or no dementia, the sensitivity of the telephone method was 0.83 (95% confidence interval 0.36, 1.00), the specificity was 1.00 (95% confidence interval 0.89,1.00). Kappa was 0.89 (95% confidence interval 0.69, 1.000). Considering a gold-standard assessment of age-associated memory impairment as cognitive impairment, the sensitivity of the telephone approach is 0.38 (95% confidence interval 0.09, 0.76) specificity 0.96 (CI 0.45, 0.89) and kappa 0.61 (CI 0.37, 0.85). CONCLUSION: Use of a telephone interview to identify people with dementia or cognitive impairment is a promising and relatively inexpensive strategy for identifying potential participants in intervention and clinical research studies and for classifying subjects in epidemiologic studies.

Evaluation of an emergency department-based enrollment program for uninsured children.

STUDY OBJECTIVE: We evaluate the effectiveness of an emergency department (ED)-based outreach program in increasing the enrollment of uninsured children. METHODS: The study involved placing a full-time worker trained to enroll uninsured children into Medicaid or the State Children's Health Insurance Program in an inner-city academic children's hospital ED. Analysis was carried out for outpatient ED visits by insurance status, average revenue per patient from uninsured and insured children, proportion of patients enrolled in Medicaid and State Children's Health Insurance Program through this program, estimated incremental revenue from new enrollees, and program-specific incremental costs. A cost-benefit analysis and breakeven analysis was conducted to determine the impact of this intervention on ED revenues. RESULTS: Five thousand ninety-four uninsured children were treated during the 10 consecutive months assessed, and 4,667 were treated during program hours. One thousand eight hundred and three applications were filed, giving a program penetration rate of 39%. Eighty-four percent of applications filed were resolved (67% of these were Medicaid). Average revenue from each outpatient ED visit for Medicaid was US135.68 dollars, other insurance was US210.43 dollars, and uninsured was US15.03 dollars. Estimated incremental revenue for each uninsured patient converted to Medicaid was US120.65 dollars. Total annualized incremental revenue was US224,474 dollars, and the net incremental revenue, after accounting for program costs, was US157,414 dollars per year. CONCLUSION: A program enrolling uninsured children at an inner-city pediatric ED into government insurance was effective and generated revenue that paid for program costs.

Process Evaluation of Practice-based Diabetes Prevention Programs: What Are the Implementation Challenges?

PURPOSE: The purpose of this report is to describe lessons learned about the feasibility of recruitment and implementation of low-income adults with prediabetes in primary care clinics into diabetes prevention programs. METHODS: Mixed methods process evaluation of a pragmatic 2-group pilot comparative effectiveness study of a community-developed Healthy Living Program (HLP) and a Diabetes Prevention Program (DPP) with 58 adults. RESULTS: Of the total (n = 1215) assessed for eligibility, 7% (n = 92) were randomized, 58 completed the baseline assessment, and 31 completed the intervention. The process evaluation identified difficulty in systematically screening potentially eligible patients. There were several logistic and staffing challenges with program planning and initial start-up. CONCLUSIONS: Addressing challenges to feasibility is required for successful translation of evidence-based programs to clinical settings.

Health literacy: why it matters to South Asian men with diabetes.

This study aims to explore the health literacy needs of South Asian men with diabetes to generate scoping data to inform culturally appropriate interventions with this group. Health literacy levels were measured using the TOFHLA-UK (n=45) and supplemented by semi-structured interviews with healthcare providers (n=12). Data suggest that the majority of participants from this cohort tend to have marginal to inadequate health literacy levels. A generational gap was also found. Although language is a common barrier, low literacy confounds this issue since some patients are unable to read even in their own language. Thus health communication and care plans need to be simplified to match current health literacy levels of South Asian men with diabetes. Interventions need to work around cultural norms and collaborate with community members. Research and interventions that consider the needs of older generations of South Asian people with diabetes are also needed.

In vivo cerebrovascular actions of amyloid beta-peptides and the protective effect of conjugated estrogens.

Vascular dysfunction and inflammatory processes may be early events in the pathology of Alzheimer's disease (AD). Even though amyloid beta-peptides (Abeta) play a prominent role in the initiation and progression of cellular dysfunction in AD, the precise in vivo actions of various Abeta-peptides has not been established. The cerebrovascular actions of the major Abeta-peptides (1-40) and (1-42) in live animals were investigated using an open cranial window technique. We show here that the Abeta-peptides cause vascular lesions, especially in the arterioles. In one set of experiments, leukocytes and platelets were tagged with Rhodamine 6G, soluble Abeta(1-40) infused intravenously for 2 minutes, and the vasculature video recorded for 90 minutes. In a second set of experiments, soluble Abeta(1-40) infusion was followed 30 minutes later by an infusion of soluble Abeta(1-42) and the vasculature recorded for 90 minutes. Fluorescent and transmission electron microscopic examinations demonstrated the following cerebrovascular action of Abeta-peptides: endothelial cell damage, leukocyte adhesion, platelet activation, thrombus formation, impeded blood flow, and smooth muscle cell damage. The vascular disruption observed were similar to those observed in the brains of some AD patients and may represent the initial phase of a vascular inflammatory response associated with cerebral amyloid angiopathy. The combination of Abeta(1-40) and (1-42) produced significantly more vascular disruption than Abeta(1-40) alone. Oral administration of conjugated estrogens in ovariectomized female rats protected them from the deleterious actions of Abeta-peptides. The reported protective effect of estrogen against AD may be mediated in part through prevention of cerebrovascular Abeta toxicity.

Photoparoxysmal responses in children: their characteristics and clinical correlates.

This study evaluates the characteristics of photoparoxysmal responses elicited with intermittent photic stimulation during a routine electroencephalogram in childhood and correlated this with the clinical profile of the child. Photoparoxysmal responses occurred in 8% (21/263) of children where activation was undertaken. Photoparoxysmal responses were often brief and had a variable onset latency. This study suggests increasing the duration of the stimulus train to 10 seconds or more will increase the diagnostic yield. Photoparoxysmal responses very rarely outlasted the stimulus, and self-limited photoparoxysmal responses probably have greater significance than previously attributed to them. They are highly correlated with epilepsy.

Internet access and patient portal readiness among patients in a group of inner-city safety-net practices.

The use of online personal health records (PHRs) threatens to transform the digital divide to a health care divide among the underserved. Little is known about underserved patients' ability to access online PHRs. We examined these factors among patients within safety-net practices. Among respondents (N = 654), only 12% had no experience of using a computer, and most were interested in using it to communicate with their provider. Age, sex, and race were not associated with interest in PHRs. A majority of patients have access to the Internet and are interested in using a PHR to manage their care, but they are not prepared.

A conceptual model of psychosocial risk and protective factors for excessive gestational weight gain.

OBJECTIVE: nearly half of all women exceed the guideline recommended pregnancy weight gain for their Body Mass Index (BMI) category. Excessive gestational weight gain (GWG) is correlated positively with postpartum weight retention and is a predictor of long-term, higher BMI in mothers and their children. Psychosocial factors are generally not targeted in GWG behaviour change interventions, however, multifactorial, conceptual models that include these factors, may be useful in determining the pathways that contribute to excessive GWG. We propose a conceptual model, underpinned by health behaviour change theory, which outlines the psychosocial determinants of GWG, including the role of motivation and self-efficacy towards healthy behaviours. This model is based on a review of the existing literature in this area. ASSESSMENT AND CONCLUSION: there is increasing evidence to show that psychosocial factors, such as increased depressive symptoms, anxiety, lower self-esteem and body image dissatisfaction, are associated with excessive GWG. What is less known is how these factors might lead to excessive GWG. Our conceptual model proposes a pathway of factors that affect GWG, and may be useful for understanding the mechanisms by which interventions impact on weight management during pregnancy. This involves tracking the relationships among maternal psychosocial factors, including body image concerns, motivation to adopt healthy lifestyle behaviours, confidence in adopting healthy lifestyle behaviours for the purposes of weight management, and actual behaviour changes. IMPLICATIONS FOR PRACTICE: health-care providers may improve weight gain outcomes in pregnancy if they assess and address psychosocial factors in pregnancy.

Safety and efficacy of moxifloxacin-dexamethasone eyedrops as treatment for bacterial ocular infection associated with bacterial blepharitis.

INTRODUCTION: Treatments that offer two medications in a fixed combination have the potential to offer efficacious and safe treatment with advantages such as a regimen that is simpler than administering two separate solutions. This study evaluated the safety and efficacy of fixed-combination versus concomitant moxifloxacin 0.5% and dexamethasone 0.1% ocular solutions for the treatment of bacterial ocular inflammation and infection. METHODS: The clinical study design was a randomized, double-masked, active-controlled, parallel-group trial of 102 subjects with bacterial blepharitis in which two patients also had bacterial conjunctivitis. All subjects received two bottles of study medication: either a fixed combination of moxifloxacin 0.5%/dexamethasone 0.1% ophthalmic solution and placebo eye drops (fixed-dose group), or moxifloxacin 0.5% ophthalmic solution and dexamethasone 0.1% (concomitant group). One drop of each study medication was instilled bilaterally four times per day for 7 days. Clinical resolution, signs, symptoms, and safety were assessed. Microbiological specimens were collected from the eyelid margin and conjunctivae of each eye from each patient at the time of enrollment and at the exit visit. RESULTS: Clinical resolution occurred similarly in both groups (81.6% of eyes, fixed-dose group; 82.3% of eyes, concomitant group). Moreover, the microbiological efficacy of the treatment was also similar for both the fixed-dose group (84%) and the concomitant group (83%). Ocular symptoms and signs improved over time, with no significant differences between groups after 7 days of treatment, except the fixed-dose group had significantly more eyes with clinical resolution in eyelid erythema (100%, n = 98/98, fixed-dose group; 92.7%, n = 89/96, concomitant group; P = 0.0194) and eyelid scaling/crusting (98%, n = 96/98, fixed-dose group; 89.6%; n = 86/96 eyes, concomitant group; P = 0.0337). Both regimens were safe and well tolerated. CONCLUSION: The fixed-dose combination of moxifloxacin, 0.5% and dexamethasone, 0.1% was therapeutically equivalent and as well tolerated as the concomitant dosage.

Longitudinal assessment of cognitive function by clock drawing in older adults.

AIMS: To test the hypotheses that performance on a clock-drawing task (CDT) diminishes over time and that poor performance is associated with development of dementia and reduced survival. METHODS: Participants in the population-based Leisure World Cohort Study were asked to complete a CDT in follow-up questionnaires mailed in 1992 and 1998. Dementia status was determined using in-person evaluations, follow-up questionnaires, hospital data, and death certificates. RESULTS: Of the 4,842 cohort members (mean age 80 years) who completed the CDT in 1992, 1,521 also completed it in 1998. Although performance in the CDT diminished over time in only a proportion of the cohort, the mean total score and the percentage of subjects with correctly drawn clocks decreased with each successive 5-year age group (p = 0.0001) and over time. Mean scores were lower in non-demented subjects later identified as demented compared with those who remained free of dementia. A low CDT score in 1992 was associated with a 28% increased risk of dementia and 13% reduced survival. CONCLUSION: A CDT may help predict cognitive decline and future disability in the elderly. Identification of high-risk individuals using a CDT may lead to earlier diagnosis and treatment and improved patient management.