The efficacy assessment of a self-administered immunotherapy protocol.
Ontology highlight
ABSTRACT: Background
We previously reported the safety of a self-administered subcutaneous immunotherapy (SCIT) protocol. Here we report the results of the retrospective efficacy trial of the United Allergy Service (UAS) self-administered SCIT protocol. We hypothesized that by utilizing a slow SCIT buildup phase, designed to attain recommended allergen concentrations on a cumulative basis, efficacious outcomes and clinical relevance would be achieved.Methods
We enrolled 60 SCIT patients and 56 control patients. The study contrasted baseline and treatment period combined symptom plus medication scores (CSMS) as the primary outcome measure and rhinoconjunctivitis quality of life questionnaire (RQLQ) scores as the secondary study outcome measure. Changes in pollen counts were also examined with regard to effects on these efficacy parameters.Results
The treatment group showed significantly improved CSMS (standardized mean difference [SMD]: -1.57; 95% confidence interval [CI], -1.97 to -1.18; p < 0.001) and RQLQ (SMD: -0.91; 95% CI, -1.23 to -0.59; p < 0.001). These treatment group outcome measures were respectively improved by 33% and 29% compared to baseline and greater than 40% in comparison to the control group (p < 0.0001). Significant results were also shown when examining these outcome measures with regards to either monotherapy or poly-allergen SCIT. Furthermore, a comparison to recent meta-analyses of SCIT studies showed equivalent efficacy and clinical relevance. Assessment of pollen counts during the baseline and treatment periods further corroborated the efficacy of the UAS SCIT protocol.Conclusion
These efficacy results, and our previous safety results, show that a carefully designed and implemented self-administered SCIT protocol is efficacious and safe.
SUBMITTER: Schaffer FM
PROVIDER: S-EPMC4860610 | biostudies-literature |
REPOSITORIES: biostudies-literature
Similar Datasets
Project description:Introduction Standardized bleeding assessment tools (BATs), such as the International Society for Thrombosis and Hemostasis (ISTH)-BAT, are screening instruments used during the diagnostic workup of suspected bleeding disorders. A self-administered ISTH-BAT (self-BAT) would enhance screening and save time during an outpatient clinic visit. Aim This study was aimed to investigate the reliability and feasibility of the self-BAT. Methods The electronic self-BAT was created from the ISTH-BAT and paper-version of self-BAT and optimized by patients and physicians. Patients with a (suspected) congenital platelet defect (CPD), who had previously undergone physician-administered ISTH-BAT assessment, were invited to complete the self-BAT. Optimal self-BAT cut-off values to detect a bleeding tendency, as defined by the ISTH-BAT, were evaluated by receiver operator characteristic (ROC) curve analysis to reach a sensitivity ≥95%. Reliability was tested by assessing sensitivity, specificity, and intraclass correlation (ICC). Feasibility was evaluated on comprehension and length of self-BAT. Results Both versions of the BAT were completed by 156 patients. Optimal cut-off values for self-BAT to define a bleeding tendency were found to be identical to those of the ISTH-BAT. Normal/abnormal scores of the ISTH-BAT and self-BAT were agreed in 88.5% (138/156, 95% confidence interval [CI]: 0.83-0.93) of patients. The sensitivity and specificity of the self-BAT to detect a bleeding tendency were 96.9 and 48.1%, respectively. The ICC was 0.73. Self-BAT questions were graded by 96.8% (151/156) as "very easy," "easy," and "satisfactory" and questionnaire length as "exactly right" by 91% (142/156) of patients. Conclusion In patients with a (suspected) CPD, the self-BAT is sufficiently reliable and feasible to detect a bleeding tendency, which supports its use as a screening tool.
| S-EPMC6884422 | biostudies-literature
Project description:Sequential testing with brief cognitive tools has been recommended to improve cognitive screening and monitoring, however the few available tools still depend on an external evaluator and periodic visits. We developed a self-administered computerized test intended for longitudinal cognitive testing (Brain on Track). The test can be performed from a home computer and is composed of several subtests, expected to evaluate different cognitive domains, all including random elements to minimize learning effects. An initial (A) and a refined version of the test (B) were applied to patients with mild cognitive impairment or early dementia (n = 88) and age and education-matched controls. A subsample of a population-based cohort (n = 113) performed the test at home every three months to evaluate test-retest reliability. The test's final version Cronbach's alpha was 0.90, test scores were significantly different between patients and controls (p = 0.001), the area under the receiver operating characteristic curve was 0.75 and the smallest real difference (43.04) was lower than the clinical relevant difference (56.82). In the test-retest reliability analysis 9/10 subtests showed two-way mixed single intraclass consistency correlation coefficient >0.70. These results imply good internal consistency, discriminative ability and reliability when performed at home, encouraging further longitudinal clinical and population-based studies.
| S-EPMC4705487 | biostudies-literature
Project description:IntroductionAs the population ages, the prevalence of cognitive impairment is expanding. Given the recent pandemic, there is a need for remote testing modalities to assess cognitive deficits in individuals with neurological disorders. Self-administered, remote, tablet-based cognitive assessments would be clinically valuable if they can detect and classify cognitive deficits as effectively as traditional in-person neuropsychological testing.MethodsWe tested whether the Miro application, a tablet-based neurocognitive platform, measured the same cognitive domains as traditional pencil-and-paper neuropsychological tests. Seventy-nine patients were recruited and then randomized to either undergo pencil-and-paper or tablet testing first. Twenty-nine age-matched healthy controls completed the tablet-based assessments. We identified Pearson correlations between Miro tablet-based modules and corresponding neuropsychological tests in patients and compared scores of patients with neurological disorders with those of healthy controls using t tests.ResultsStatistically significant Pearson correlations between the neuropsychological tests and their tablet equivalents were found for all domains with moderate (r > 0.3) or strong (r > 0.7) correlations in 16 of 17 tests (p < 0.05). All tablet-based subtests differentiated healthy controls from neurologically impaired patients by t tests except for the spatial span forward and finger tapping modules. Participants reported enjoyment of the tablet-based testing, denied that it provoked anxiety, and noted no preference between modalities.ConclusionsThis tablet-based application was found to be widely acceptable to participants. This study supports the validity of these tablet-based assessments in the differentiation of healthy controls from patients with neurocognitive deficits in a variety of cognitive domains and across multiple neurological disease etiologies.
| S-EPMC10247386 | biostudies-literature
Project description:IntroductionDepression is a common debilitating disease that affects individuals in all age groups. The impact of the diagnosis extends beyond the individual, with negative effects on mental health, physical health and social well-being. Self-efficacy has been referenced as an important aspect to the prognosis of mood disorders by conferring co-responsibility to the affected individual to face his/her health problems. Several assessment tools are found in the literature for measuring self-efficacy, but it is not yet clear which of these measures are more applicable to individuals with mood disorders, particularly depression. Thus, the aim of present study is to propose a systematic review to examine the psychometric properties and applicability of assessment tools designed to measure self-efficacy in individuals with symptoms and/or a diagnosis of depression.Methods and analysisThis protocol is reported in accordance with the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols statement and the review will be reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. The evaluation of the psychometric properties of the health outcome measures will be conducted according to COSMIN guidelines. Two independent reviewers will perform the electronic searches in the PubMed, Web of Science, PsycInfo, SCOPUS and CINAHL databases, followed by the use of the 'snowball' strategy. The inclusion criteria will be (1) instrument validation studies, (2) developed with individuals of any age (3) with symptoms or a diagnosis of depression. Two independent reviewers will analyse the titles and abstracts of the articles retrieved during the search for pre-selection, followed by full-text analyses to determine inclusion in the review based on the eligibility criteria. Cases of a divergence of opinion will be resolved by a third reviewer. Descriptive analysis of the articles will be performed (data on participants, characteristics, psychometric properties and clinical usefulness of the assessment tools).Ethics and disseminationThe proposed systematic review will provide information on assessment tools employed to measure self-efficacy with regard to coping with depression, offering data on the psychometric properties, strong and weak points, and clinical applicability. As a secondary analysis of the literature, the approval of an ethics committee is not required.Prospero registration numberCRD42017078707.
| S-EPMC6589040 | biostudies-literature
Project description:BackgroundFriedreich's ataxia is an inherited, progressive, neurodegenerative disease that typically begins in childhood. Disease severity is commonly assessed with rating scales, such as the modified Friedreich's Ataxia Rating Scale, which are usually administered in the clinic by a neurology specialist.ObjectiveThis study evaluated the utility of home-based, self-administered digital endpoints in children with Friedreich's ataxia and unaffected controls and their relationship to standard clinical rating scales.MethodsIn a cross-sectional study with 25 participants (13 with Friedreich's ataxia and 12 unaffected controls, aged 6-15 years), home-based digital endpoints that reflect activities of daily living were recorded over 1 week. Domains analyzed were hand motor function with a digitized drawing, automated analysis of speech with a recorded oral diadochokinesis test, and gait and balance with wearable sensors.ResultsHand-drawing and speech tests were easy to conduct and generated high-quality data. The sensor-based gait and balance tests suffered from technical limitations in this study setup. Several parameters discriminated between groups or correlated strongly with modified Friedreich's Ataxia Rating Scale total score and activities of daily living total score in the Friedreich's ataxia group. Hand-drawing parameters also strongly correlated with standard 9-hole peg test scores.InterpretationDeploying digital endpoints in home settings is feasible in this population, results in meaningful and robust data collection, and may allow for frequent sampling over longer periods of time to track disease progression. Care must be taken when training participants, and investigators should consider the complexity of the tasks and equipment used.
| S-EPMC8419399 | biostudies-literature
Project description:BackgroundOur objective was to safely and remotely assess longitudinal SARS-CoV-2 seroprevalence in at-risk health care workers at the onset of the epidemic.MethodsSelf-administered serologic testing was performed every 30 days up to 5 times using a point-of-care, lateral flow SARS-CoV-2 nucleocapsid IgG immunoassay in a cohort of at-risk health care workers (n = 339) and lower-risk controls (n = 100).ResultsSubjects were enrolled between 4/14/20-5/6/20 and most were clinicians (41%) or nurses (27%). Of 20 subjects who reported confirmed SARS-CoV-2 infection prior to (n = 5, 1%) or during the study (n = 15, 3%), half (10/20) were seropositive. Five additional subjects were seropositive and did not report documented infection. Estimated infection rates in health care workers did not differ from concurrent community rates.ConclusionsThis remotely conducted, contact-free study did not identify serologic evidence of widespread occupational SARS-CoV-2 infection in health care workers.
| S-EPMC8906004 | biostudies-literature
Project description:INTRODUCTION:The abuse of alcohol and other drugs is a worldwide problem, the treatment of which poses a challenge to healthcare workers. OBJECTIVE:This study presents a proposal for a systematic review to analyse the psychometric properties of assessment tools developed to measure the self-efficacy of drug users with regard to resisting the urge to take drugs in high-risk situations. METHODS AND ANALYSIS:The guiding question was based on PICOS (Population Intervention Comparator Outcome Setting), and the report of the methods of review protocol was written in accordance with the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P). Searches will be performed in the PsycINFO, Cochrane, Pubmed, Web of Science, SCOPUS and CINAHL databases, followed by the use of the 'snowball' strategy. The inclusion criteria for the articles will be (1) assessment tool validation studies; (2) assessment tools developed to measure self-efficacy; (3) quantitative measures; (4) measures designed for use on adults; (5) data from self-reports of the participants; (6) studies involving a description of psychometric properties of the measures; and (7) studies that explain how the level of self-efficacy is scored. The search, selection and analysis will be performed by two independent reviewers. In cases of a divergence of opinion, a third reviewer will be consulted. The COSMIN checklist will be used for the appraisal of the methodological quality of the assessment tools and the certainty of the evidence in the articles (risk of bias) will be analysed using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach. ETHICS AND DISSEMINATION:This protocol does not require ethical approval. However, this protocol is part of the thesis entitled Drug-Taking Confidence Questionnaire for use in Brazil, presented for obtaining a doctorate in neuropsychiatry and behavioural sciences from the Federal University of Pernambuco, and has received approval from the human research ethics committee of the Federal University of Pernambuco (reference number: 1.179.162).The results will be disseminated to clinicians and researchers through peer-reviewed publications and conferences. PROSPERO REGISTRATION NUMBER:CRD42017068555.
| S-EPMC5857662 | biostudies-literature
Project description:Background: Many authors regard counseling self-efficacy (CSE) as important in therapist development and training. The purpose of this study was to examine the factor structure, reliability, and validity of the German version of the Counselor Activity Self-Efficacy Scales-Revised (CASES-R). Method: The sample consisted of 670 German psychotherapy trainees, who completed an online survey. We examined the factor structure by applying exploratory and confirmatory factor analysis to the instrument as a whole. Results: A bifactor-exploratory structural equation modeling model with one general and five specific factors provided the best fit to the data. Omega hierarchical coefficients indicated optimal reliability for the general factor, acceptable reliability for the Action Skills-Revised (AS-R) factor, and insufficient estimates for the remaining factors. The CASES-R scales yielded significant correlations with related measures, but also with therapeutic orientations. Conclusion: We found support for the reliability and validity of the German CASES-R. However, the subdomains (except AS-R) should be interpreted with caution, and we do not recommend the CASES-R for comparisons between psychotherapeutic orientations.
| S-EPMC8716828 | biostudies-literature
Project description:BACKGROUND:Cognitive impairment is common in patients with multiple sclerosis (MS). Accurate and repeatable measures of cognition have the potential to be used as markers of disease activity. METHODS:We developed a 5-min computerized test to measure cognitive dysfunction in patients with MS. The proposed test - named the Integrated Cognitive Assessment (ICA) - is self-administered and language-independent. Ninety-one MS patients and 83 healthy controls (HC) took part in Substudy 1, in which each participant took the ICA test and the Brief International Cognitive Assessment for MS (BICAMS). We assessed ICA's test-retest reliability, its correlation with BICAMS, its sensitivity to discriminate patients with MS from the HC group, and its accuracy in detecting cognitive dysfunction. In Substudy 2, we recruited 48 MS patients, 38 of which had received an 8-week physical and cognitive rehabilitation programme and 10 MS patients who did not. We examined the association between the level of serum neurofilament light (NfL) in these patients and their ICA scores and Symbol Digit Modalities Test (SDMT) scores pre- and post-rehabilitation. RESULTS:The ICA demonstrated excellent test-retest reliability (r?=?0.94), with no learning bias, and showed a high level of convergent validity with BICAMS. The ICA was sensitive in discriminating the MS patients from the HC group, and demonstrated high accuracy (AUC?=?95%) in discriminating cognitively normal from cognitively impaired participants. Additionally, we found a strong association (r?=?-?0.79) between ICA score and the level of NfL in MS patients before and after rehabilitation. CONCLUSIONS:The ICA has the potential to be used as a digital marker of cognitive impairment and to monitor response to therapeutic interventions. In comparison to standard cognitive tools for MS, the ICA is shorter in duration, does not show a learning bias, and is independent of language.
| S-EPMC7236354 | biostudies-literature
Project description:IntroductionImpulsivity is present in a range of mental disorders and has been associated with suicide. Traditional measures of impulsivity have certain limitations, such as the lack of ecological validity. Virtual reality (VR) may overcome these issues. This study aims to validate the VR assessment tool 'Spheres & Shield Maze Task' and speech analysis by comparing them with traditional measures. We hypothesise that these innovative tools will be reliable and acceptable by patients, potentially improving the simultaneous assessment of impulsivity and decision-making.Methods and analysisThis study will be carried out at the University Hospital Fundación Jiménez Díaz (Madrid, Spain). Our sample will consist of adults divided into three groups: psychiatric outpatients with a history of suicidal thoughts and/or behaviours, psychiatric outpatients without such a history and healthy volunteers. The target sample size was established at 300 participants (100 per group). Participants will complete the Barratt Impulsiveness Scale 11; the Urgency, Premeditation, Perseverance, Sensation Seeking, Positive Urgency, Impulsive Behaviour Scale; Iowa Gambling Task; Continuous Performance Test; Stop signal Task, and Go/no-go task, three questions of emotional affect, the Spheres & Shield Maze Task and two satisfaction surveys. During these tasks, participant speech will be recorded. Construct validity of the VR environment will be calculated. We will also explore the association between VR-assessed impulsivity and history of suicidal thoughts and/or behaviour, and the association between speech and impulsivity and decision-making.Ethics and disseminationThis study was approved by the Ethics Committee of the University Hospital Fundación Jiménez Díaz (PIC128-21_FJD). Participants will be required to provide written informed consent. The findings will be presented in a series of manuscripts that will be submitted to peer-reviewed journals for publication.Trial registration numberNCT05109845; Pre-results.
| S-EPMC9280903 | biostudies-literature