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PubMed1977

[How blind is a double-blind trial really? Validity of controlled investigations].

During a double blind trial lasting 4 weeks (Diazepam versus Loxapin), two investigators tried to identify the given drug prematurely. Only the more experienced investigator was able to identify the two drugs (p = 0.01). His judgement was based neither on observation of side-effects nor on a clinical improvement but apparently on a summary of particular subtle effects, the cognition of which requires a specific experience. The use of an adequate comparative drug instead of a placebo in a double blind study does not completely prevent a premature decoding but should reduce this risk and therefore increase the validity of the method.

Anxiety↗

PubMed1993

["To be blind", blindness between an epidemiological and a sociological definition].

From an epidemiological point of view, blindness refers to a visual acuity inferior to 1/20 in each eye. Though such a definition is necessary for the installation of public health programs, it is insufficient as far as the elaboration of actions aimed at prevention and rehabilitation are concerned. Qualitative data reveal that a similar physical deficiency is lived in various ways according to precise social context. In addition to the physical handicap objectively defended and to its social interpretation, the same must also be analysed in the light of another important linking factor; the individuals' social status and specific task and obligations of various groups in a given population. Considered together, these factors provide a better understanding of the social condition of blind persons, their economic and matrimonial resulting in the conception of appropriate health programs.

Activities of Daily Living↗

PubMed1993

[Haptic mental rotation in patients with congenital blindness, acquired blindness and normal vision persons].

Nineteen congenitally blind subjects (Ss), eleven Ss who went blind later in their life, and 42 control Ss with normal vision were tested in a tactile version of a "mental rotation" task. A specially constructed tactile display was used which enabled a rotation of the alphanumeric symbols in multiples of 60 degrees without any form distortion. Ss had to compare two successively presented symbols regarding whether the second was just a rotated version or also a mirror image of the first. Decision latencies and errors were recorded. Neither of dependent variables reveal any differences between the three groups of subjects. Moreover, the well known linear increase of decision latency as a function of angular disparity could also be observed with the tactile stimuli in all three groups. Both results are consistent with the assumption that mental rotation effects are neither linked to the visual modality nor to a manipulation of visual-analog representations. If the task is solved by so called analog processes then these seem to operate with non-visual spatial representations.

Adult↗

PubMed1998

[Borderline blindness, practical blindness and severe visual debility].

In the presented paper the author explains assessment aspect of social welfare departments as regard evaluation of complete of practical blindness with reference to generally blinding legal regulations. The author draws attention to another interpretation not consistent with these regulations, in chapter 26 of the Compendium of Ophthalmology (Grada 1997) and recommends ophthalmologists to use a procedure which will prevent imminent difficulties which could arise as a result of the interpretation in chapter 26 of the Compendium.

Blindness↗

PubMed1999

Agreement between 'time-blind' and 'time-non-blind' assessments of depressive symptomatology.

In a 4-week study, two methods were used simultaneously in the assessment of depressive symptomatology with videotaped structured clinical interviews: a 'time-non-blind' (TNB) method (chronological order, observer aware of the previous duration of drug treatment) and a 'time-blind' (TB) method (no chronological order, rater unaware of the previous duration of treatment). Sixty newly admitted depressed inpatients with Montgomery-Asberg Depression Rating Scale scores higher than 20 were assessed before (D0), after 10 days (D10) and after 28 days (D28) of antidepressant treatment. Agreement between TNB and TB methods on the Montgomery-Asberg Depression Rating Scale, measured by intra-class correlation coefficients, was good at D0 (0.68), excellent at D10 (0.81) and D28 (0.86), but not significantly different between D0, D10 and D28. The statistical method of Bland and Altman (1986) was also used to evaluate the degree of agreement. Results of this second analysis were in accordance with the intra-class correlation coefficient results, and showed significantly (P < 0.05) higher D0-D28 and D10-D28 intrasubject changes with the TB method, which were largely accounted for by some particular items (inner tension, pessimism, lassitude). With the Clinical Global Impression-Severity score, the Bland and Altman method failed to show significant differences between the two methods, and compared with the Montgomery-Asberg Depression Rating Scale, intra-class correlation coefficients were lower with larger confidence intervals, suggesting that global ratings are less reliable than itemized symptom ratings.

Adolescent↗

PubMed2002

Circadian genes in a blind subterranean mammal II: conservation and uniqueness of the three Period homologs in the blind subterranean mole rat, Spalax ehrenbergi superspecies.

We demonstrated that a subterranean, visually blind mammal has a functional set of three Per genes that are important components of the circadian clockwork in mammals. The mole rat superspecies Spalax ehrenbergi is a blind subterranean animal that lives its entire life underground in darkness. It has degenerated eyes, but the retina and highly hypertrophic harderian gland are involved in photoperiodic perception. All three Per genes oscillate with a periodicity of 24 h in the suprachiasmatic nuclei, eye, and harderian gland and are expressed in peripheral organs. This oscillation is maintained under constant conditions. The light inducibility of sPer1 and sPer2, which are similar in structure to those of other mammals, indicates the role of these genes in clock resetting. However, sPer3 is unique in mammals and has two truncated isoforms, and its expressional analysis leaves its function unresolved. Per's expression analysis in the harderian gland suggests an important participation of this organ in the stabilization and resetting mechanism of the central pacemaker in the suprachiasmatic nuclei and in unique adaptation to life underground.

Animals↗

PubMed2004

From blind signal extraction to blind instantaneous signal separation: criteria, algorithms, and stability.

This paper reports a study on the problem of the blind simultaneous extraction of specific groups of independent components from a linear mixture. This paper first presents a general overview and unification of several information theoretic criteria for the extraction of a single independent component. Then, our contribution fills the theoretical gap that exists between extraction and separation by presenting tools that extend these criteria to allow the simultaneous blind extraction of subsets with an arbitrary number of independent components. In addition, we analyze a family of learning algorithms based on Stiefel manifolds and the natural gradient ascent, present the nonlinear optimal activations (score) functions, and provide new or extended local stability conditions. Finally, we illustrate the performance and features of the proposed approach by computer-simulation experiments.

Algorithms↗

PubMed1976

How double blind is double blind? And does it matter?

In an apparently double blind crossover study, two experienced measurement technicians were able to identify many of the treatment periods. They most often correctly identified aspirin, a drug with prominent effects and side effects. It is argued that in many circumstances it is better to use a blind observer who is not concerned with the giving of treatment or the collection of side effects.

Arthritis, Rheumatoid↗

PubMed1995

An information-maximization approach to blind separation and blind deconvolution.

We derive a new self-organizing learning algorithm that maximizes the information transferred in a network of nonlinear units. The algorithm does not assume any knowledge of the input distributions, and is defined here for the zero-noise limit. Under these conditions, information maximization has extra properties not found in the linear case (Linsker 1989). The nonlinearities in the transfer function are able to pick up higher-order moments of the input distributions and perform something akin to true redundancy reduction between units in the output representation. This enables the network to separate statistically independent components in the inputs: a higher-order generalization of principal components analysis. We apply the network to the source separation (or cocktail party) problem, successfully separating unknown mixtures of up to 10 speakers. We also show that a variant on the network architecture is able to perform blind deconvolution (cancellation of unknown echoes and reverberation in a speech signal). Finally, we derive dependencies of information transfer on time delays. We suggest that information maximization provides a unifying framework for problems in "blind" signal processing.

Algorithms↗

PubMedDate not supplied

Diagnosis of ventilator-associated pneumonia: focus on nonbronchoscopic techniques (nonbronchoscopic bronchoalveolar lavage, including mini-BAL, blinded protected specimen brush, and blinded bronchial sampling) and endotracheal aspirates.

The ideal diagnostic approach for ventilator-associated pneumonia currently is based on invasive procedures to obtain respiratory tract cultures. Given the lack of consensus and relatively poor acceptance of full bronchoscopic bronchoalveolar lavage (BAL) and protected specimen brush (PSB), less invasive procedures have been developed. We review the nonbronchoscopic procedures (nonbronchoscopic bronchoalveolar lavage, including mini-BAL, blinded protected specimen, and blinded bronchial sampling) and endotracheal aspiration. We provide a critique of the methods used, the types of catheters inserted, and the sample collection methods. Most studies were flawed in that antibiotic use before initiation of the procedure was not controlled. The variability of both the methods and the criteria for the gold standard in the numerous investigations show that these procedures are neither standardized nor proven to be accurate and often did not improve management. Pending future studies, use of endotracheal aspirates without the use of quantitation seems to be a reasonable approach for clinicians who are not committed to an invasive procedure.

Bronchi↗

PubMed1988

Supplemental security income for the aged, blind and disabled; presumptive disability and presumptive blindness; categories of impairments--AIDS--Social Security Administration, HHS. Final rule.

We may pay benefits to a person applying for supplemental security income benefits on the basis of disability or blindness before making a formal determination when available information indicates a high probability that disability exists. These findings of presumptive disability and blindness may be made at the Social Security district offices only for specified impairment categories; at the State agencies, they may be made for any impairment category. We are publishing final rules which add acquired immunodeficiency syndrome (AIDS) to these categories in view of the predictability that the disease will result in a finding of disability.

Acquired Immunodeficiency Syndrome↗

PubMed2003

Thresholds of clinical reactivity to milk, egg, peanut and sesame in immunoglobulin E-dependent allergies: evaluation by double-blind or single-blind placebo-controlled oral challenges.

BACKGROUND: The prevalence of food anaphylaxis due to masked allergens has increased within the last 10 years. Contamination of manufactured products by food allergens is a key concern for food industries. OBJECTIVE: To determine quantities eliciting reactions in patients who have an IgE-dependent food allergy, thanks to standardized oral provocation tests. To evaluate the subsequent levels of sensitivity required for the detection tests of allergens for egg, peanut, milk and sesame. METHODS: Prick-in-prick tests, Cap system RAST, and single or double-blind placebo-controlled food challenges (SBPCFC or DBPCFC) were performed. The doses of natural food were gradually increased from 5 to 5000 mg for solid food and from 1 to 30 mL for peanut oil, sunflower oil, soy oil and sesame oil. RESULTS: Data from 125 positive oral challenges to egg, 103 to peanut, 59 to milk and 12 to sesame seeds were analysed. Haemodynamic modifications were observed in 2%, 3%, 1.7%, and 8% of the oral challenges (OCs) to egg, peanut, milk and sesame, respectively. Respiratory symptoms were observed in 12%, 20%, 10% and 42% of egg, peanut milk and sesame allergies, respectively. A cumulative reactive dose inferior or equal to 65 mg of solid food or 0.8 mL of milk characterized 16%, 18%, 5% and 8% of egg, peanut, milk and sesame allergies, respectively. 0.8% of egg allergies, 3.9% of peanut allergies, and 1.7% of milk allergies reacted to 10 mg or less of solid food or to 0.1 mL for milk. The lowest reactive threshold has been observed at less than 2 mg of egg; 5 mg of peanut, 0.1 mL of milk and 30 mg of sesame seed. Ten out of 29 OC with peanut oil, two out of two OC with soy oil and three out of six OC with sunflower oil were positive. Five out six OC with sesame oil were positive: 1 and 5 mL induced an anaphylactic shock. CONCLUSION: The risk of asthma and anaphylactic shock to sesame and peanut is confirmed. Minimal reactive quantities show that, in order to guarantee a 95% safety for patients who are allergic to egg, peanut and milk, and on the basis of consumption of 100 g of food, the detection tests should ensure a sensitivity of 10 p.p.m. for egg, 24 p.p.m. for peanut and 30 p.p.m. for milk proteins. Oil allergies being considered, the limit of sensitivity should fall to 5 p.p.m.

Administration, Oral↗

PubMed1986

How blind is blind? Assessment of patient and doctor medication guesses in a placebo-controlled trial of imipramine and phenelzine.

The purpose of the double blind is to protect the internal validity of a clinical trial by preventing knowledge of treatment conditions from influencing outcome or its assessment. We studied medication guesses of 137 depressed patients and/or their doctors at the end of a 6-week randomized trial of placebo, imipramine, and phenelzine. Overall, 78% of the patients and 87% of the doctors correctly distinguished between placebo and active medication. Clinical outcome, treatment condition, and their interaction each contributed to guessing accuracy, while medication experience and side effects assessed only in week 6 did not. Accuracy was high, however, even when cases were stratified for clinical outcome, indicating that other cues were available to the patients and doctors. These may include patterns and timing of side effects and clinical response not detectable in this end-point analysis.

Adolescent↗

PubMed1996

Low molecular weight heparin (reviparin) in percutaneous transluminal coronary angioplasty. Results of a randomized, double-blind, unfractionated heparin and placebo-controlled, multicenter trial (REDUCE trial). Reduction of Restenosis After PTCA, Early Administration of Reviparin in a Double-Blind Unfractionated Heparin and Placebo-Controlled Evaluation.

OBJECTIVES: The specific objective of the REDUCE trial was to evaluate the effect of low molecular weight heparin on the incidence and occurrence of restenosis in patients undergoing percutaneous transluminal coronary angioplasty (PTCA). BACKGROUND: Unfractionated heparin and its low molecular weight fragments possess antiproliferative effects and have been shown to reduce neointimal smooth muscle cell migration and proliferation in response to vascular injury in experimental studies. METHODS: The REDUCE trial is an international prospective, randomized, double-blind, multicenter study. Twenty-six centers in Europe and Canada enrolled 625 patients with single-lesion coronary artery obstructions suitable for PTCA. Three hundred six patients received reviparin as a 7,000-U bolus before PTCA, followed by 10,500 U as an infusion over 24 h and then twice-daily 3,500-U subcutaneous application for 28 days. The 306 patients in the control group received a bolus of 10,000 U of unfractionated heparin followed by an infusion of 24,000 U over 24 h. These patients then underwent 28 days of subcutaneous placebo injections. The primary end points were efficacy (defined as a reduction in the incidence of major adverse events [i.e., death, myocardial infarction, need for reintervention or bypass surgery]), absolute loss of minimal lumen diameter and incidence of restenosis during the observation period of 30 weeks after PTCA. RESULTS: Using the intention to treat analysis for all patients, 102 (33.3%) in the reviparin group and 98 (32%) in the control group have reached a primary clinical end point (relative risk [RR] 1.04, 95% confidence interval [CI] 0.83 to 1.31, p = 0.707). Likewise, no difference in late loss of minimal lumen diameter was evident for both groups. Acute events within 24 h occurred in 12 patients (3.9%) in the reviparin group and 25 (8.2%) in the control group (RR 0.49, 95% CI 0.26 to 0.92, p = 0.027) during or immediately after the initial procedure. In the control group, eight major bleeding complications occurred, and in the reviparin group, seven were observed within 35 days after PTCA. CONCLUSIONS: Reviparin use during and after coronary angioplasty did not reduce the occurrence of major clinical events or the incidence of angiographic restenosis over 30 weeks.

Angioplasty, Balloon, Coronary↗

PubMed1999

Double-blind comparison [correction of Double-blind, placebo-controlled comparison] of rabeprazole 20 mg vs. omeprazole 20 mg in the treatment of erosive or ulcerative gastro-oesophageal reflux disease. The European Rabeprazole Study Group.

BACKGROUND: Rabeprazole sodium is the most recent member of a class of substituted benzimidazole molecules known as proton pump inhibitors. Other proton pump inhibitors have been shown to be effective in healing oesophagitis. METHODS: In this randomised, double-blind, multicentre study, conducted at 27 European sites, the efficacy and safety of rabeprazole and omeprazole were compared in patients with erosive or ulcerative gastro-oesophageal reflux disease (GERD).100 patients received rabeprazole 20 mg, and 102 patients omeprazole 20 mg once daily for 4 or 8 weeks, with healing monitored by endoscopy. RESULTS: Overall GERD healing rates observed and evaluated at weeks 4 and 8 were equivalent. Four-week healing rates for rabeprazole and omeprazole were 81%-81% and 92%-94% for 8-week healing. Rabeprazole-treated patients had similar relief of the frequency and intensity of heartburn to those treated with omeprazole. Both drugs were well tolerated over the 8-week treatment period. Mean changes in fasting serum gastrin were comparable. No significant differences in laboratory parameters were seen. Biopsies for argyrophil ECL cell histology at the end-point revealed a similar distributions of hyperplasia grades to those at baseline in both groups. Biopsies of body and antral mucosa for other parameters were similar between treatments for Helicobacter pylori colonization, presence or degree of inflammation, atrophy or intestinal metaplasia at the end-point. CONCLUSION: In this study, GERD healing rates following rabeprazole 20 mg once daily were equivalent to those obtained with omeprazole 20 mg once daily. Both treatments resulted in a comparable relief of the frequency and intensity of heartburn associated with this disease, and both were well tolerated.

2-Pyridinylmethylsulfinylbenzimidazoles↗

PubMed2000

[Randomized double-blind study (third place blinded) to examine the effectiveness and side effects of methacholine in the nonspecific bronchial provocation test].

Softly and effectiveness of methacholine for the diagnosis of non-specific bronchial hyperresponsiveness [BHR] were tested in a third place blinded study. 61 patients suspected to suffer from BHR took part. 56 subjects provided complete data and were included in the study. 27 participants were challenged with methacholine 0.33% (verum) and 29 patients received NaCl 0.9% (placebo). The challenge was applied as 5-step-test using a storage bag. The doses were elevated by doubling the aerosol volume. A positive test result was assumed when basal specific airway resistance (sRt) reduplicated and simultaneously 2.0 (kPa*s) was attained. Ten out of 27 subjects in the verum group (33.3%) had a positive test result whereas in the placebo group only one subject showed a reaction (3.5%). A statistically significant association between the change of sRt and the cumulative methacholine dose was confirmed in the verum group (p < 0.002), whereas this effect could not be observed in patients challenged with placebo (p = 0.20). Side effects did not occur. We conclude that inhalative challenge with methacholine 0.33% applied as a 5-step-test is suitable to objectify BHR. The substantial benefit of the applied test scheme is the short range of time in which the challenge can be performed (approximately 20 min) and that dilution series of the test substance (methacholine 0.33%) are not required.

Adult↗

PubMed1981

Do the blind hear better? Investigations on auditory processing in congenital or early acquired blindness. II. Central functions.

The same 18 normally hearing students and 18 matched normal-sighted students, as in part I of this study, were compared in regard to pure-tone integration, speech discrimination ability and late cortical-evoked potentials. The blind subjects showed increased disinhibition ('cleaning') with broad-band noise and a decreased inhibition with the same stimulus at the contralateral ear, better speech discrimination, especially with regard to sentence tests without and with competing environment-simulating noise, and, by electric response audiometry (ERA), a shortened N1 latency. Thus, the hypothesis of a better utilization of auditory information after the loss of the visual information channel could be confirmed, and may be ascribed to the plasticity of the central nervous system.

Adult↗

PubMed1989

[Hereditary diseases of the eye and their relative significance among the causes of blindness and diminished vision in the pupils of boarding schools for blind and amblyopic children in Uzbekistan].

At the present time about 2000 hereditary diseases are known, 246 pathologic genes leading to eye pathology are described. Diagnostics of these diseases is important for correct treatment, prognosis and rehabilitation. Results of examinations, conducted by the authors, of 1843 pupils of boarding-schools for blind and poor-sighted children in Uzbekistan were identified with 87 nosologic forms of hereditary eye diseases which can develop among the contingents of pupils of these schools. Hereditary diseases were diagnosed in 1005 (54%) examined children. The hereditary character of this pathology is confirmed by results of genealogical examination, combination of eye pathologies, associated diseases of internal organs and systems in the examined children.

Amblyopia↗