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Results for “Blinding integrity”

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At least 19 recordsLinked to original sources
PubMed2026

Redefining the real problem in psychedelic trials: Why fighting the Lessebo matters more than blinding integrity.

Imperfect blinding is not specific to psychedelic trials. In randomized trials, treatment allocation is frequently correctly guessed, yet blinding integrity is rarely assessed outside of psychedelic research and is generally not considered a barrier in regulatory evaluation. The intense debate in psychedelics may reflect a broader double standard affecting mental health research, when uncertainties arising from imperfect blinding are confounded by those linked to patient-reported outcome measures. Indeed, people living with mental disorders are often viewed as unreliable reporters, despite well-documented limitations of clinician-rated scales and the absence of robust biological markers of symptomatic change. Importantly, it is the maintenance of reasonable doubt of treatment allocation that sustains internal validity and ethical feasibility of placebo-controlled designs, rather than perfect blinding. Concerns about expectancy bias in psychedelic trials are closely tied to blinding debates. When allocation is inferred, expectations may cluster in the arm perceived as active or in stereotyped experiences and influence outcomes differently in active and control arms, leading to a risk of lessebo, a negative placebo effect due to the negative expectation related to receiving a placebo. However, we argue that an underrecognized mechanism of lessebo is disappointment. This risk may reflect insufficient clinical management of disappointment rather than pre-treatment expectation alone. We therefore propose shifting the emphasis from preserving inevitably imperfect blinding towards mitigating disappointment in both arms. Establishing non-stereotyped expectations prior to treatment through structured psychoeducation, strengthened therapeutic alliance, and realistic preparation would help avoid lessebo effects. Such strategies would enhance ethical rigor, interpretability, and the clinical usefulness of psychedelic trials.

Humans↗
PubMed2026

Blinding integrity in psychedelic research: Evidence from a comparative randomized controlled trial of psilocybin, MDMA, and methylphenidate in healthy volunteers.

Maintaining effective blinding is a major methodological challenge in psychedelic research. This study provides a comprehensive evaluation of blinding integrity in 120 healthy volunteers who received either psilocybin, MDMA, or methylphenidate (active placebo) in a double-blind, randomized controlled trial. Using a multi-level assessment incorporating forced-choice substance guesses, certainty ratings, decision factors, and subjective substance effects, the analyses characterize blinding integrity and its relation to the substance experience. Results indicate that overall blinding was insufficient, with psilocybin showing the highest rates of functional unblinding, MDMA moderate levels, and methylphenidate the lowest. As an active placebo, methylphenidate provided more effective blinding for MDMA than for psilocybin. Incorporating certainty levels of substance guesses revealed a more differentiated pattern, with lower functional unblinding rates. Decision factors and subjective substance experiences were associated with phenomenological substance effects. Prior substance experiences did not influence accuracy of forced-choice substance guesses. These findings provide empirical guidance for the design and reporting of blinding procedures in psychedelic trials and underscore the value of systematic, multi-level assessment of blinding integrity.

Humans↗
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↗
PubMed1979

Integrating the physically handicapped child.

This paper will serve several purposes: (1) to provide information on the incidence of physically handicapped children (exclusive of the blind and deaf) who are likely to be integrated into schools for normal non-physically impaired children, (2) to describe briefly the major handicapping conditions and their educational implications, (3) to comment on why integration has come about and why it promises to enrich the lives of normal children, (4) to suggest how physicians, physical therapists, and occupational therapists might help to make schools programs successful, (5) to comment briefly on financial implications of this program and to suggest ways in which the complexity of the medical management might be simplified, (6) to provide factual knowledge about the handicapped child and his potential to teachers who are already on the firing line to "improve" the academic achievement of the alleged normal child.

Arthritis, Juvenile↗
PubMed1975

Betamethasone valerate in corticosteroid-dependent asthmatics. The integrity of the hypothalamic pituitary adrenal axis.

In a single-blind trial 29 patients with corticosteroid-dependent asthma reduced their daily dose of oral prednisolone by 1 mg/week while using a placebo inhaler until an unacceptable degree of asthma occurred. Betamethasone-17-vlaerate in a dose of 800 mug/day and if necessary 1600 mug/day was then substituted for the placebo inhaler and the reduction of oral prednisolone continued until the prednisolone was withdrawn completely or an unacceptable degree of asthma recurred. In 22 patients (76%) prednisolone was withdrawn completely, 11 on 800 mug and 11 on 1600 mug betamethasone-17-valerate. The mean reduction of prednisolone was 3-8 mg on placebo, 5-4 mg on 800 mug and a further 1-8 mg in patients requiring 1600 mug of betamethasone-17-valerate. The hypothalamic pituitary adrenal (HPA) axis was assessed by tetracosactrin and insulin stress tests at the start of the study and after withdrawal of oral prednisolone. The results indicate that an HPA axis which is completely suppressed by systemic corticosteroids can regain normal integrity when the systemic steroid is replaced by betamethasone-17-valerate in a dose of either 800 mug/day or 1600 mug/day. Candidiasis was observed, but will be reported later.

Adrenal Glands↗
PubMed1977

Technetium-99m pyrophosphate myocardial uptake in patients with stable angina pectoris.

99m-technetium (Tc) pyrophosphate myocardial scintigrams of 55 patients with stable angina pectoris were compared with those of 13 normal subjects. The mean scintigraphic score, obtained by averaging the blinded interpretations of four readers scoring on an integral scale from 0 to 4, was significantly higher for the patients with angina than for the control subjects (1.36 compared with 0.48, P less than 0.001). Among the patients with angina, those who had a prior myocardial infarction had a higher mean scintigraphic grade than those without a previous infarction (1.73 versus 1.15, P less than 0.005), and the mean grade in both groups was higher than that of control subjects (P less than 0.001). Radionuclide uptake was predominantly diffuse in the patients with angina pectoris (70%), although in those with greater uptake accumulation tended to be localized. Three of the 68 subjects had high levels of radionuclide uptake but no clinical evidence of acute myocardial injury. This study demonstrates that excess myocardial accumulation of 99m-Tc pyrophosphate can occur in patients with stable angina pectoris.

Angina Pectoris↗
PubMed2026

Effects of multistrain probiotic supplementation on hepatic function and anthropometric parameters in patients with metabolic dysfunction-associated steatotic liver disease: a double-blind, randomized controlled trial.

BACKGROUND: Metabolic dysfunction-associated steatotic liver disease (MASLD) is increasingly prevalent on a global scale. The gut microbiota is integral to its pathogenesis, prompting extensive research into microbiota modulation as a potential adjunctive therapeutic strategy. AIM: The study aimed to evaluate the effect of multistrain probiotics supplementation on hepatic function in patients with MASLD in a double-blind, randomized, controlled trial. The primary outcomes were changes in Fibrosis-4 index (FIB-4) and fatty liver index (FLI). Secondary outcomes included changes in anthropometric parameters, selected biochemical markers, and other liver-related indices. METHODS: A total of 64 patients with MASLD were randomly assigned to two groups receiving either placebo (C) or a probiotic mixture (PRO) containing the following bacterial strains: 50% Lactococcus lactis Rosell-1058, 25% Lacticaseibacillus casei Rosell-215, 12.5% Lactobacillus helveticus Rosell-52, 12.5% Bifidobacterium bifidum Rosell-71 for 12 wk. RESULTS: Significant group &#xd7; time interactions were observed for FIB-4 (Q = 0.007), with reduction in the PRO group and increase in the C group (-0.05 vs. 0.10; P = 0.002). No significant interaction was found for FLI (Q = 0.942). Significant group &#xd7; time interactions were also observed for aspartate aminotransferase (-2.87 vs. 1.87 U/L; Q = 0.003) and APRI (-0.03 vs. 0.02; Q = 0.001), favoring the PRO group (P < 0.001 for both). No significant changes were observed in anthropometric parameters, glucose levels, or lipid profile. CONCLUSIONS: In patients with MASLD, the 12-wk probiotic supplementation had a modest but statistically significant effect on FIB-4, aspartate aminotransferase, and APRI, with no significant effect on FLI or anthropometric and metabolic parameters. These findings suggest that this probiotic formulation may have potential benefits for liver function in MASLD. However, long-term studies incorporating imaging-based and histological endpoints are required to determine the clinical significance of these findings.

Humans↗
PubMed2026

Blue light therapy delivered through light glasses improves sleep quality and daytime sleepiness in Parkinson's disease: A randomized trial.

BackgroundSleep disturbances, including excessive daytime sleepiness (EDS) and fragmented nocturnal sleep, are common in Parkinson's disease (PD) and significantly reduce quality of life. This pilot study evaluated the efficacy of a novel approach using blue light, delivered via dedicated glasses with integrated LED lights, to improve sleep and non-motor symptoms.MethodsRandomised, placebo-controlled, single-blind pilot study with a 2-week light intervention. Participants were assessed at baseline, two weeks, and five weeks. The study was designed to evaluate between- and within-group changes. Participants were randomly allocated to receive blue light therapy (n&#x2009;=&#x2009;15) or red light placebo (n&#x2009;=&#x2009;15), delivered via LED-integrated glasses for one hour, twice daily, given for a 2-week period. Primary outcome was improvement in sleep quality, assessed via the Pittsburgh Sleep Quality Index. Secondary outcomes included diary-based sleep outcomes, excessive daytime sleepiness, mood, anxiety, and motor symptoms.ResultsThere was a significant group&#x2009;&#xd7;&#x2009;time effect with blue light therapy leading to better Pittsburgh Sleep Quality Index scores (p&#x2009;=&#x2009;0.021). Between-group analyses showed that at two weeks a trend toward significance was observed (p&#x2009;=&#x2009;0.065), while sleep quality significantly improved at five weeks compared to placebo (p&#x2009;=&#x2009;0.029) with a large effect size (0.896). Excessive sleepiness improved in the blue light group (p&#x2009;<&#x2009;0.001), with a reduction in clinically relevant sleepiness from 50.0% to 6.7% (p&#x2009;=&#x2009;0.005).ConclusionsBlue light therapy delivered through dedicated glasses appeared to show an improvement in sleep quality and daytime sleepiness in individuals with PD. Blue light therapy offers a promising alternative to traditional light therapy utilising lower light intensities and eliminating the need for light boxes.

Aged↗
PubMed2026

Assessing the threat of Bacillus cereus: From toxin characterization to modern detection strategies.

Bacillus cereus is a spore-forming pathogen responsible for both diarrheal and emetic foodborne illnesses worldwide. Its significance in food safety has received growing attention. Recent advances, including the discovery of novel virulence factors and the development of emerging detection technologies, have provided new insights into its pathogenic mechanisms and surveillance strategies. This review critically examines the global burden of B. cereus infections, and molecular mechanisms of its major virulence factors, and the performance characteristics of current detection knowledge gaps such as the viable-but-non-culturable state and regulatory blind spots for emetic toxins, and discuss unresolved challenges in clinical management. By integrating epidemiological, microbiological, and technological perspectives with critical lens, this review aims to provide a valuable reference for future research and food safety practices.

Bacillus cereus↗
PubMed2026

A bimodal large language model reduces misalignment in patient education: A double-blinded randomized trial.

BACKGROUND: Effective patient education requires accurate communication aligned with patients' emotional and semantical needs. Text-based large language models (LLMs) lack access to non-verbal cues, which may contribute to misaligned responses. METHODS: We evaluated emotional and semantic misalignment in a text-based LLM using 64,200 utterances from 16,583 patient education cases across six departments and three centers. Dolphin was developed integrating text and audio cues and evaluated through emotion recognition, semantic consistency assessment, branch-level ablations, and a double-blinded randomized trial against a matched text-based LLM comparator (Chinese Clinical Trial Registry: (ChiCTR2500095933). FINDINGS: The text-based LLM showed emotional misalignment in 36.7% of responses and semantic misalignment in 28.3% of cases, with higher misalignment under greater burden. Dolphin outperformed the text-based LLM in emotion recognition accuracy (0.886 vs. 0.713) and semantic consistency (84.9% vs. 82.1%; both adjusted p < 0.001). Ablations supported contribution of audio branches. Dolphin received higher expert ratings than the text-based LLM and human educators (all p < 0.001). In 555 patients, Dolphin was associated with greater patient satisfaction (98.6% vs. 93.8%), suggestion acceptance (76.1% vs. 58.9%; p < 0.001), proactive disclosure (44.6% vs. 26.5%; p < 0.001), and fewer 7-day unplanned recontact (12.9% vs. 22.9%; p = 0.002). No unsafe recommendations or safety events were identified. CONCLUSIONS: Compared with text-based LLM, Dolphin improved emotional-semantic alignment and patient-education outcomes, supporting bimodal alignment as a strategy for reducing misalignment-driven communication failures. FUNDING: National Natural Science Foundation of China, State Key Laboratory Special Fund, and Chinese Academy of Medical Sciences Innovation Fund.

Humans↗
PubMed1978

Research needs in low vision.

Research needs are presented for several areas of low vision: (1) reading and learning, (2) new low-vision aids, (3) modifying the environment, (4) utilization of disciplines, (5) new technologies, and (6) integrating low-vision services.

Audiovisual Aids↗
PubMed2025

Whole-genome automated assembly pipeline for Chlamydia trachomatis strains from reference, in vitro and clinical samples using the integrated CtGAP pipeline.

Whole genome sequencing (WGS) is pivotal for the molecular characterization of Chlamydia trachomatis (Ct)-the leading bacterial cause of sexually transmitted infections and infectious blindness worldwide. Ct WGS can inform epidemiologic, public health and outbreak investigations of these human-restricted pathogens. However, challenges persist in generating high-quality genomes for downstream analyses given its obligate intracellular nature and difficulty with in vitro propagation. No single tool exists for the entirety of Ct genome assembly, necessitating the adaptation of multiple programs with varying success. Compounding this issue is the absence of reliable Ct reference strain genomes. We, therefore, developed CtGAP-Chlamydia trachomatisGenome Assembly Pipeline-as an integrated 'one-stop-shop' pipeline for assembly and characterization of Ct genome sequencing data from various sources including isolates, in vitro samples, clinical swabs and urine. CtGAP, written in Snakemake, enables read quality statistics output, adapter and quality trimming, host read removal, de novo and reference-guided assembly, contig scaffolding, selective ompA, multi-locus-sequence and plasmid typing, phylogenetic tree construction, and recombinant genome identification. Twenty Ct reference genomes were also generated. Successfully validated on a diverse collection of 363 samples containing Ct, CtGAP represents a novel pipeline requiring minimal bioinformatics expertise with easy adaptation for use with other bacterial species.

Chlamydia trachomatis↗
PubMed1975

Recovery of function after brain injury in man.

Late after-effects of cerebral trauma are difficult to study because patients tend to be seen for persisting symptoms, and not simply for their lesions. We have tried to avoid this bias by recalling periodically, over the years, 520 men with known brain injuries incurred in World War II or in Korea or Vietnam. These men are seen irrespective of clinical need and all undergo intensive behavioural and neurological assessment, which still continues. For such groups, recovery is impressive, though one third shows persistent intellectual loss. In addition, some tasks reveal specific deficits enduring unchanged, after th first 2-3 yr, for the 20-30 yr of follow-up (e.g. visual field defects, certain auditory discrimination losses, trouble on various complex perceptual tasks). These lasting deficits are linked to the site and size of focal injury, often representing remnants of more severe initially-present disorders. The extent of recovery is correlated with age at the time of trauma, the youngest faring best. Extension of such studies to cases of early brain damage (birth to five years), as indicated by hemiparesis, shows the familiar 'escape' of language after early left-hemisphere lesions but this is achieved at a price, the price being borne by non-verbal functions that normally depend on the integrity of the right hemisphere.

Age Factors↗
PubMed1977

Spatial and visuomotor performance with agenesis of the corpus callosum.

The extent to which the cerebral hemispheres and their ipsilateral projection systems compensate for congenital absence of the corpus callosum was studied in an intelligent young adult with radiologically verified total agenesis. She was found to have bilateral speech and the ability to readily integrate visual, tactile, and verbal information simultaneously presented to both hemispheres. However, spatial performance, as demonstrated in blind tactile form board learning, was subnormal compared to normal controls. The results further suggest this impairment, especially severe in the nondominant hand, reflects ipsilateral projection of kinesthetic input, thus maximizing hemispheric competition for motor control of the minor hand. In contrast, the agenic's performance on a simple visuomotor discrimination task (with reduced opportunity for hemispheric interaction) was almost normal. Moreover, she exhibited a doubling of attentional and processing capacity in comparison to the control group. Both hands simultaneously performed this task as rapidly and as accurately as either hand alone. The findings affirm the functionally important, yet limited compensatory role of a developmentally elaborated ipsilateral somatosensory projection system in agenesis of the corpus callosum.

Adult↗
PubMed1979

Free-running circadian plasma cortisol rhythm in a blind human subject.

The plasma cortisol rhythm in man has been presumed to be an endogenous circadian rhythm, synchronized by some external stimulus to an exact 24-h period. Sleep/wake and 'social activity' cycles have been considered as candidates for this synchronizer. Previous studies have suggested that the dark/light phase shifts associated with the sleep-wake cycle may be the external synchronizer, rather than the sleep/wake cycle itself. A totally blind, but otherwise normal subject was studied for a period of 50 days. Her hourly sleep/wake status and hourly integrated mean plasma cortisol concentrations were determined, and the data were subjected to non-parametric mathematical analysis. The subject was found to have a free-running rhythm in plasma cortisol with a period of approximately 24.5 h. Her sleep/wake rhythm, determined by similar analysis, had a period of exactly 24 h. In addition to the dominant 24.5-h cortisol rhythm, there appeared to be a minor 24-h cortisol rhythm with a peak that coincided approximately with the time of awakening. It was not possible to determine whether this sleep/wake-related peak represented a minor component of the circadian rhythm, synchronized by some stimulus associated with sleep/wake activity, or merely an acute response to awakening itself. Nevertheless, the two rhythms exhibited 'beating' behaviour, resulting in maximal peak cortisol concentrations when they were in synchrony and minimal peak concentrations when they were not. It is concluded that environment dark/light phase shifts are the dominant synchronizer of the circadian rhythm in plasma cortisol concentrations in man, as they are for a variety of circadian rhythms in other living things.

Blindness↗
PubMed1977

Correlation between kinesthetic discrimination & manual dexterity.

Sixteen early-blinded adults and 16 normally sighted adults performed tests of manual dexterity and kinesthetic discrimination to determine whether or not a significant positive correlation exists between the two skills for each group. Manual dexterity was measured by the Minnesota Rate of Manipulation Test, Displacing and Turning tests. Kinesthetic discrimination was measured by the Kinesthesiometer Test and Kinesthesia Test of the Southern California Sensory Integration Tests. The Spearman Rank Order Correlation formula yielded a significant positive correlation (p less than .05) between manual dexterity and kinesthetic discrimination for the blind and sighted groups.

Adult↗
PubMed1978

Positive occipital sharp transients of sleep in the blind.

Positive occipital sharp transients of sleep (POSTS) were evaluated in 23 legally blind subjects. Only those subjects with severe visual field defects but normal or near normal visual acuity showed this activity. Nineteen subjects with visual acuity of 20/200 or worse failed to exhibit these potentials, while a control group matched for age showed POST in 79 percent of cases. The production of POSTS appears to depend on the integrity of macular function and normal central visual acuity.

Adult↗