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PubMed2003

Large capacity storage of integrated objects before change blindness.

Normal people have a strikingly low ability to detect changes in a visual scene. This has been taken as evidence that the brain represents only a few objects at a time, namely those currently in the focus of attention. In the present study, subjects were asked to detect changes in the orientation of rectangular figures in a textured display across a 1600 ms gray interval. In the first experiment, change detection improved when the location of a possible change was cued during the interval. The cue remained effective during the entire interval, but after the interval, it was ineffective, suggesting that an initially large representation was overwritten by the post-change display. To control for an effect of light intensity during the interval on the decay of the representation, we compared performance with a gray or a white interval screen in a second experiment. We found no difference between these conditions. In the third experiment, attention was occasionally misdirected during the interval by first cueing the wrong figure, before cueing the correct figure. This did not compromise performance compared to a single cue, indicating that when an item is attentionally selected, the representation of yet unchosen items remains available. In the fourth experiment, the cue was shown to be effective when changes in figure size and orientation were randomly mixed. At the time the cue appeared, subjects could not know whether size or orientation would change, therefore these results suggest that the representation contains features in their 'bound' state. Together, these findings indicate that change blindness involves overwriting of a large capacity representation by the post-change display.

Attention↗
PubMed1979

Sensory integration in the rehabilitation of blind adults.

Learning difficulties displayed by the blind adult prompted an investigation of a link with sensory integrative dysfunction. A review of the literature provided evidence that tactile and vestibular deficiencies were prevalent within this population. Through observational assessment, sensory integrative dysfunction was identified in a number of clients and individual sensory integrative treatment programs were initiated. In the three case studies presented, improvements were noted in mobility, activities of daily living, handwriting, and behaviour after six months of treatment. A discussion is provided on those deficit areas responding to sensory integrative treatment.

Activities of Daily Living↗
PubMed2006

A generic minimization random allocation and blinding system on web.

BACKGROUND: Minimization is a dynamic randomization method for clinical trials. Although recommended by many researchers, the utilization of minimization has been seldom reported in randomized trials mainly because of the controversy surrounding the validity of conventional analyses and its complexity in implementation. However, both the statistical and clinical validity of minimization were demonstrated in recent studies. Minimization random allocation system integrated with blinding function that could facilitate the implementation of this method in general clinical trials has not been reported. SYSTEM OVERVIEW: The system is a web-based random allocation system using Pocock and Simon minimization method. It also supports multiple treatment arms within a trial, multiple simultaneous trials, and blinding without further programming. METHODS: This system was constructed with generic database schema design method, Pocock and Simon minimization method and blinding method. It was coded with Microsoft Visual Basic and Active Server Pages (ASP) programming languages. And all dataset were managed with a Microsoft SQL Server database. Some critical programming codes were also provided. SIMULATIONS AND RESULTS: Two clinical trials were simulated simultaneously to test the system's applicability. Not only balanced groups but also blinded allocation results were achieved in both trials. DISCUSSIONS AND CONCLUSIONS: Practical considerations for minimization method, the benefits, general applicability and drawbacks of the technique implemented in this system are discussed. Promising features of the proposed system are also summarized.

Clinical Trials as Topic↗
PubMedDate not supplied

Effects of hyaluronic acid/carboxymethylcellulose gel on bowel anastomoses in the New Zealand white rabbit.

Intra-abdominal adhesions form in more than 90% of patients undergoing major abdominal surgery and can lead to significant complications. Application of a bioresorbable gel consisting of chemically modified hyaluronic acid (HA) and carboxymethylcellulose (CMC) has shown promise as a means of preventing intra-abdominal adhesions, but there have been concerns that the presence of the gel might interfere with the integrity and healing of bowel anastomoses. We tested the effects of HA/CMC gel on adhesion formation and anastomotic healing in 60 New Zealand white rabbits after transection and complete (100%) or incomplete (90%) anastomosis of the ileum. Half of the animals underwent application of HA/CMC gel and half served as control subjects. Animals were killed at 4, 7, or 14 days after surgery. Anastomotic adhesions were scored in a blinded fashion. Integrity of the anastomosis was tested by measuring bursting pressure at the anastomotic site and in an adjacent section of intact bowel. With complete anastomosis, HA/CMC gel significantly reduced adhesion formation at 7 and 14 days after surgery (P<0.05), but gel application did not inhibit adhesion formation when the anastomosis was incomplete. Anastomosed segments of bowel burst at a lower pressure than intact bowel 4 days after surgery, but bursting pressures were normal at 7 and 14 days. Burst pressures of anastomoses receiving an application of HA/CMC gel were nearly identical to control anastomoses at all three time points. HA/CMC gel did not interfere with the normal healing process of bowel anastomoses. Furthermore, HA/CMC gel decreased adhesion formation after complete anastomoses, yet it did not affect adhesion formation in the presence of anastomotic disruption.

Anastomosis, Surgical↗
PubMed2002

Effect of irrigation solutions for arthroscopic surgery on intraarticular tissue: comparison in human meniscus-derived primary cell culture between lactate Ringer's solution and saline solution.

In order to determine whether there is a difference in effect on cell morphology and function between two common arthroscopic irrigation solutions, primary cultures of cells derived from the surgically excised human menisci were incubated for 3 or 6 h in lactated Ringer's solution, isotonic sodium chloride solution, or serum-free cell culture medium (negative-control condition). Cell integrity was blindly evaluated by three independent examiners scoring photomicrographs of the cell cultures on a battery of five-point scales for abnormality of cell shape, irregularity of cell membrane, change of cell size and cell density. Cell cultures were also quantitatively assayed by semi-quantitative reverse-transcription-polymerase-chain-reaction for mRNA of alpha1 (I) procollagen, alpha1 (II) procollagen, aggrecan and heat-shock protein 70 to assess functional consequences of exposure to the solutions. There was a statistically significant difference in cell integrity scores between either lactated Ringer's solution or serum-free cell-culture medium and isotonic sodium chloride solution with greater damage to cells displayed. Scores for lactated Ringer's solution did not differ from those for serum-free cell-culture medium. There were no significant differences in mRNA expression level among the treatment conditions. It was concluded that the lactated Ringer's solution better maintained human meniscus cell integrity than the isotonic saline.

Adolescent↗
PubMed2000

Effectiveness and tolerability of zafirlukast for the treatment of asthma in children.

OBJECTIVE: This study was undertaken to examine the dose-response relationship of zafirlukast (5 to 40 mg BID) and to assess the efficacy and tolerability of the 10-mg BID dose in school-aged children with mild to moderate asthma. BACKGROUND: The efficacy and tolerability of zafirlukast, an oral leukotriene-receptor antagonist, has been demonstrated in adolescents and adults aged > or = 12 years. METHODS: Data from 2 placebo-controlled, parallel-group, multicenter trials (trial 1, 4-week double-blind; trial 2, 6-week double-blind) were integrated. Children aged 5 to 11 years were randomly assigned to receive zafirlukast 5 mg BID (n = 99), 10 mg BID (n = 205), 20 mg BID (n = 105), 40 mg BID (n = 99), or placebo (n = 206). The primary outcome was change from baseline in forced expiratory volume in 1 second (FEV1) expressed as percent of predicted normal. Secondary outcomes were FEV1 (L), morning and evening peak expiratory flow, peak flow variability, short-acting beta2-agonist use, asthma episode score, and nights awakened by asthma. RESULTS: Mean baseline FEV1 was 76.5% of predicted. The greatest improvements were generally seen with zafirlukast 5 mg BID or 10 mg BID, with no additional clinically significant benefits seen at higher doses. The pooled data analysis showed that 10 mg BID compared with placebo significantly improved (P < 0.045) all efficacy outcomes except asthma-episode score and nights awakened with asthma. However, in the subset of children who had > or = 1 night awakened per week at baseline (zafirlukast 10 mg BID = 78; placebo = 86), 10 mg BID significantly reduced nights awakened (P = 0.009) (mean difference from placebo at end point = -0.81 night/wk). All zafirlukast doses were well tolerated and had tolerability profiles that were clinically indistinguishable from placebo. CONCLUSION: These results support the effectiveness and tolerability of the 10-mg BID dose of zafirlukast for the prophylaxis and chronic treatment of mild to moderate asthma in children.

Adolescent↗
PubMed2000

An implicit measure of undetected change.

Several paradigms (e.g. change blindness, inattentional blindness, transsaccadic integration) indicate that observers are often very poor at reporting changes to their visual environment. Such evidence has been used to suggest that the spatio-temporal coherence needed to represent change can only occur in the presence of focused attention. However, those studies almost always rely on explicit reports. It remains a possibility that the visual system can implicitly detect change, but that in the absence of focused attention, the change does not reach awareness and consequently is not reported. To test this possibility, we used a simple change detection paradigm coupled with a speeded orientation discrimination task. Even when observers reported being unaware of a change in an item's orientation, its final orientation effectively biased their response in the orientation discrimination task. Both in aware and unaware trials, errors were most frequent when the changed item and the probe had incongruent orientations. These results demonstrate that the nature of the change can be represented in the absence of awareness.

Awareness↗
PubMed2006

Efficacy and tolerability of dapoxetine in treatment of premature ejaculation: an integrated analysis of two double-blind, randomised controlled trials.

BACKGROUND: No drugs are approved for treatment of premature ejaculation. Our aim was to determine the efficacy and tolerability of on-demand dapoxetine in patients with severe premature ejaculation. METHODS: We determined the efficacy of dapoxetine in a prospectively predefined integrated analysis of two 12-week randomised, double-blind, placebo-controlled, phase III trials of identical design done independently, in parallel, at 121 sites in the USA. Men with moderate-to-severe premature ejaculation in stable, heterosexual relationships took placebo (n=870), 30 mg dapoxetine (874), or 60 mg dapoxetine (870) on-demand (as needed, 1-3 h before anticipated sexual activity). The primary endpoint was intravaginal ejaculatory latency time (IELT) measured by stopwatch. Safety and tolerability were assessed. All analyses were done on an intention-to-treat basis. The trials are registered at ClinicalTrials.gov, numbers NCT00211107 and NCT00211094. FINDINGS: 672, 676, and 610 patients completed in the placebo, 30 mg dapoxetine, and 60 mg dapoxetine groups, respectively. Dapoxetine significantly prolonged IELT (p<0.0001, all doses vs placebo). Mean IELT at baseline was 0.90 (SD 0.47) minute, 0.92 (0.50) minute, and 0.91 (0.48) minute, and at study endpoint (week 12 or final visit) was 1.75 (2.21) minutes for placebo, 2.78 (3.48) minutes for 30 mg dapoxetine, and 3.32 (3.68) minutes for 60 mg dapoxetine. Both dapoxetine doses were effective on the first dose. Common adverse events (30 mg and 60 mg dapoxetine, respectively) were nausea (8.7%, 20.1%), diarrhoea (3.9%, 6.8%), headache (5.9%, 6.8%), and dizziness (3.0%, 6.2%). INTERPRETATION: On-demand dapoxetine is an effective and generally well tolerated treatment for men with moderate-to-severe premature ejaculation.

Adult↗
PubMed1994

Dextromethorphan for the treatment of neuropathic pain: a double-blind randomised controlled crossover trial with integral n-of-1 design.

The aim was to compare the analgesic effectiveness and adverse effect incidence of oral dextromethorphan (DM) with placebo in patients with neuropathic pain. The first 10-day treatment period was a multiple-dose double-blind randomised controlled cross-over comparison of 13.5 mg of DM 3 times a day (t.d.s.) with placebo t.d.s.: 5 treatment pairs, each pair 1 day DM and 1 day placebo. The second 10-day treatment period used 27 mg of DM t.d.s. vs. placebo, with the same design. The study incorporated a 5 pair n-of-1 design for each of the 2 doses of DM. Patients took the study medication in addition to any pre-existing analgesic regime. Patients who reported benefit could continue with DM after the study. Nineteen patients with chronic neuropathic pain were studied over two 10-day treatment periods. Outcome measures were pain intensity, pain relief, adverse effects, mood, sleep and global rating of treatment. These were recorded by daily patient diaries and by clinic assessments before and after each treatment period. There were no significant differences between DM and placebo on any of the clinic assessment outcome measures. Two patients had significantly better analgesia on more than one outcome measure on within-patient testing. One had better analgesia with DM. The other had better analgesia with placebo. Ten patients had no adverse effects on either dose of DM. Two patients withdrew during the first treatment period because of adverse effects (which included increased pain intensity), and 5 during the second period. Five patients continued with DM after the study for 1-3 months. No long-term clinical benefit was apparent in those who continued with open DM. Dextromethorphan at either 40.5 or 81 mg daily did not relieve neuropathic pain.

Adult↗
PubMed2006

An integrated analysis of five double-blind, randomized controlled trials evaluating the safety and efficacy of a hyaluronan product for intra-articular injection in osteoarthritis of the knee.

OBJECTIVE: Five double-blind, randomized, saline-controlled trials (RCTs) were included in the United States marketing application for an intra-articular hyaluronan (IA-HA) product for the treatment of osteoarthritis (OA) of the knee. We report an integrated analysis of the primary Case Report Form (CRF) data from these trials. METHOD: Trials were similar in design, patient population and outcome measures - all included the Lequèsne Algofunctional Index (LI), a validated composite index of pain and function, evaluating treatment over 3 months. Individual patient data were pooled; a repeated measures analysis of covariance was performed in the intent-to-treat (ITT) population. Analyses utilized both fixed and random effects models. Safety data from the five RCTs were summarized. RESULTS: A total of 1155 patients with radiologically confirmed knee OA were enrolled: 619 received three or five IA-HA injections; 536 received "placebo" saline injections. In the active and control groups, mean ages were 61.8 and 61.4 years; 62.4% and 58.8% were women; baseline total Lequèsne scores 11.03 and 11.30, respectively. Integrated analysis of the pooled data set found a statistically significant reduction (P < 0.001) in total Lequèsne score with hyaluronan (HA) (-2.68) vs placebo (-2.00); estimated difference -0.68 (95% CI: -0.56 to -0.79), effect size 0.20. Additional modeling approaches confirmed robustness of the analyses. CONCLUSIONS: This integrated analysis demonstrates that multiple design factors influence the results of RCTs assessing efficacy of intra-articular (IA) therapies, and that integrated analyses based on primary data differ from meta-analyses using transformed data.

Aged↗
PubMed2000

Clinician, parent, and child prediction of medication or placebo in double-blind depression study.

To evaluate how well a blind is maintained in a double-blind study. Clinicians (n = 66), parents (n = 62), and depressed child/adolescent subjects (n = 62) predicted whether the patient had been on either placebo or active medication at the end of an eight-week double-blind placebo versus fluoxetine trial. Clinician, patient and parents' guesses as to which treatment they had received were at a chance level based on an overall analysis. However, when clinical response and condition assignment were controlled, all were correctly predicting placebo treatment but not medication treatment. The finding that subjects, parents and clinicians predict at a chance level is important for double-blind study design integrity. However, clinicians, parents and subjects were accurately predicting placebo treatment when clinical response and the assigned condition were taken into account but not medication. Since they do not know condition however, all remain essentially blinded, and this is an important finding for design and analysis integrity for double-blind studies.

Adolescent↗
PubMed2001

Integration of children with visual impairment in regular preschools.

The current practice in Germany is to integrate children who are blind or partially sighted into regular preschools providing they exhibit no further severe impairments. The present study asked 72 regular preschool teachers about their experiences in integrating 24 children who were blind and 16 who were partially sighted. Results showed that integration seemed to be unproblematic except for greater emotional difficulties in children who are partially sighted. According to preschool teachers, integrating children who are blind is far more complex and difficult than integrating the partially sighted. One fifth of the blind exhibited marked to serious problems in 10 out of 28 preschool activities surveyed. Most of these difficulties involved manual, cognitive, interactive and daily living skills. When asked about difficulties that had not been anticipated before integration commenced, preschool teachers emphasized four domains: the increase in their own workload; the children's problems with concentration and motivation; fixation on one preschool teacher; and difficulties in the fine- and gross-motor domain as well as in daily living skills. Findings indicate the need for improved preparations and support when integrating the blind into regular preschool.

Adult↗
PubMed1997

Circular trajectory formation during blind locomotion: a test for path integration and motor memory.

Eight healthy subjects were asked to walk blindfolded along circular paths of different radii after several practice trials with vision. Their task was to stop after completing two full revolutions. They always walked counter-clockwise (CCW) in (a) a control condition (CONTROL), including the instructions mentioned above, (b) with the further instruction to count backwards in twos (MENTAL), (c) with the instruction to count loudly (LOUD). The movement of two markers lying along the head naso-occipital axis was recorded by means of an ELITE system. Total walked distance (DISTANCE), total head turning angle (ANGLE) and average radius (RADIUS) of the trajectories performed were measured. All subjects were able to perform approximately circular trajectories. They consistently overshot the ideal radius independently of the condition and circle size, undershot the total angle and overshot total distance. The LOUD condition induced greater errors in the performance but only on total distance (P<0.05). A strong correlation was found between the errors in radius and total distance but not between distance and total angle. Principal components analysis suggested that radius and distance share a common source of errors while total angle produced independent errors. The results indicate that (a) circular trajectories can be generated starting from spatial and/or motor memory, without the aid of visual information; (b) the task needs some attentional control and does not involve simple automatic processing of afferent information; (c) different sensory information or different processing modes are probably involved in the estimation of the curvature and length of the walked path on the one hand, and of the total rotation angle on the other.

Adult↗
PubMed2001

Navigating without vision: basic and applied research.

We describe some of the results of our program of basic and applied research on navigating without vision. One basic research topic that we have studied extensively is path integration, a form of navigation in which perceived self-motion is integrated over time to obtain an estimate of current position and orientation. In experiments on pathway completion, one test of path integration ability, we have found that subjects who are passively guided over the outbound path without vision exhibit significant errors when attempting to return to the origin but are nevertheless sensitive to turns and segment lengths in the stimulus path. We have also found no major differences in path integration ability among blind and sighted populations. A model we have developed that attributes errors in path integration to errors in encoding the stimulus path is a good beginning toward understanding path integration performance. In other research on path integration, in which optic flow information was manipulated in addition to the proprioceptive and vestibular information of nonvisual locomotion, we have found that optic flow is a weak input to the path integration process. In other basic research, our studies of auditory distance perception in outdoor environments show systematic underestimation of sound source distance. Our applied research has been concerned with developing and evaluating a navigation system for the visually impaired that uses three recent technologies: the Global Positioning System, Geographic Information Systems, and virtual acoustics. Our work shows that there is considerable promise of these three technologies in allowing visually impaired individuals to navigate and learn about unfamiliar environments without the assistance of human guides.

Animals↗
PubMedDate not supplied

Naltrexone versus acamprosate: one year follow-up of alcohol dependence treatment.

Naltrexone and acamprosate reduce relapse in alcohol dependence. They have not yet been compared in a published trial. The aim of this study was to compare the efficacy of these compounds in conditions similar to those in routine clinical practice. Random allocation to a year of treatment with naltrexone (50 mg/day) or acamprosate (1665-1998 mg/day) was made in 157 recently detoxified alcohol-dependent men with moderate dependence (evaluated using the Addictions Severity Index and Severity of Alcohol Dependence Scale). All were patients whom a member of the family would accompany regularly to appointments. Alcohol consumption, craving and adverse events were recorded weekly for the first 3 months, and then bi-weekly, by the treating psychiatrist who was not blinded. At 3-monthly intervals, investigators who were blinded to the treatment documented patients' alcohol consumption based on patients' accounts, information given by the psychiatrists when necessary, and reports from patients' families. Serum gamma-glutamyltransferase (GGT) was also measured. Efforts were made to sustain the blindness of the investigators. The same investigator did not assess the same patient twice. The integrity of the blindness was not checked. There was no difference between treatments in mean time to first drink (naltrexone 44 days, acamprosate 39 days) but the time to first relapse (five or more drinks in a day) was 63 days (naltrexone) versus 42 days (acamprosate) (P = 0.02). At the end of 1 year, 41% receiving naltrexone and 17% receiving acamprosate had not relapsed (P = 0.0009). The cumulative number of days of abstinence was significantly greater, and the number of drinks consumed at one time and severity of craving were significantly less, in the naltrexone group compared to the acamprosate group, as was the percentage of heavy drinking days (P = 0.038). More patients in the acamprosate than the naltrexone group were commenced on disulfiram during the study. Naltrexone patients attended significantly more group therapy sessions, though this could not explain their better outcome. There were non-significant trends for the naltrexone group to comply better with medication, to stay in the study longer, and to show greater improvement over baseline in serum GGT.

Acamprosate↗