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《Vaccine》2022,40(6):924-933
The European Clinical Trial Regulation No 536/2014 is the first mandate for a non-technical, publicly disclosed, plain language summary (PLS) of clinical trial results. This easy-to-understand summary has the potential to inform the public about clinical trial results and thereby improve health literacy in vaccines.To investigate the utility of the PLS, we undertook 2 online surveys (July/October 2020) in the United Kingdom, the United States and India. Participants were selected by quota sampling to ensure representation of gender, age and parental status. Those lacking interest in vaccine clinical research were excluded. In survey 1, participants were questioned about their interest in and expectations of vaccine trial results. In survey 2, the perceptions of participants to a range of written communication styles used in publicly available PLSs were evaluated.A total of 66 (13%) and 122 (29%) individuals were excluded solely due to lack of interest in vaccine clinical research in surveys 1 and 2, respectively; 450 respondents (150/country) completed survey 1 and 300 (100/country) completed survey 2. In survey 1, there was a correlation (p < 0.01) between claimed knowledge of and trust in vaccines. Healthcare professionals were the most trusted source for vaccine information, while vaccine companies were ranked relatively low. In survey 2, infographic PLS formats were considered easiest to understand, most engaging and the strongest communicators. Emphasizing the main points of the infographics in the text did not improve comprehension or recall. Most respondents (86%) indicated that they would like to see this type of communication in the future.Overall, this research suggests that the PLS, by optimizing content and format, has a potential to increase health literacy, and thereby, as part of a wider integrated communication strategy, build vaccine knowledge and confidence. 相似文献
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《Vaccine》2021,39(33):4742-4750
Allogeneic hematopoietic stem cell transplantation (alloHSCT) results in a loss of humoral immunity and subsequent risk for severe infections. Thus, re-vaccination is required but may fail due to incomplete immune reconstitution. We retrospectively analyzed predictors of immune response to primary vaccination applied according to the EBMT (European Blood and Marrow Transplantation Group) recommendations. Serologic response to vaccination against diphtheria (D), tetanus (T), Bordetella pertussis (aP) and Haemophilus influenzae (Hib) (administrated as combined DTaP-Hib-IPV vaccination) was studied in 84 alloHSCT patients transplanted between 2008 and 2015 (age at alloHSCT: 18.6–70.6 years). All patients with a relapse-free survival of ≥9 months, at least 3 consecutive vaccinations and absence of intravenous immunoglobulin administration within 3 months before and after vaccination met the primary inclusion criteria. Additionally, immunological response to a pneumococcal conjugate vaccine was analyzed in a subgroup of 67 patients. Patients’ characteristics at the time of first vaccination were recorded. Responses were measured as vaccine-specific antibody titers. Regarding DTaP-Hib-IPV vaccination, 89.3% (n = 75) of all patients achieved protective titers to at least 3 of the 4 vaccine components and were thus considered responders. 10.7% (n = 9) of the patients were classified as non-responders with positive immune response to less than 3 components. Highest response was observed for Hib (97.4%), tetanus (95.2%) and pneumococcal vaccination (83.6%) while only 68.3% responded to vaccination against Bordetella pertussis. Significant risk factors for failure of vaccination response included low B cell counts (p < 0.001; cut-off: 0.05 B cells/nl) and low IgG levels (p = 0.026; mean IgG of responders 816 mg/dl vs. 475 mg/dl of non-responders). Further, a trend was observed that prior cGvHD impairs vaccination response as 88.9% of the non-responders but only 54.7% of the responders had prior cGvHD (p = 0.073). The results demonstrate, that the currently proposed vaccination strategy leads to seroprotection in the majority of alloHSCT patients. 相似文献
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《The Journal of emergency medicine》2020,58(4):691-697
BackgroundDischarge against medical advice (AMA) is an important, yet understudied, aspect of health care—particularly in trauma populations. AMA discharges result in increased mortality, increased readmission rates, and higher health care costs.ObjectiveThe goal of this analysis was to determine what factors impact a patient's odds of leaving the hospital prior to treatment.MethodsWe performed a retrospective analysis of the National Trauma Data Bank on adult trauma patients (older than 14 years) from 2013 to 2015. Of the 1,770,570 patients with known disposition, excluding mortality, 24,191 patients (1.4%) left AMA. We ascertained patient characteristics including age, sex, race, ethnicity, insurance status, ETOH, drug use, geographic location, Injury Severity Score (ISS), injury mechanism, and anatomic injury location. Multivariate logistic regression models were used to determine which patient factors were associated with AMA status.ResultsUninsured (odds ratio [OR] 2.72; 95% confidence interval [CI] 2.58–2.86) or Medicaid-insured (OR 2.50; 95% CI 2.37–2.63) trauma patients were significantly more likely to leave AMA than patients with private insurance. Compared to white patients, African-American patients (OR 1.06; 95% CI 1.02–1.11) were more likely, and Native-American (OR 0.62; 95% CI 0.52–0.75), Asian (OR 0.59; 95% CI 0.49–0.69), and Hispanic (OR 0.80; 95% CI 0.75–0.85) patients were less likely, to leave AMA when controlling for age, sex, ISS, and type of injury.ConclusionsInsurance status, race, and ethnicity are associated with a patient's decision to leave AMA. Uninsured and Medicaid patients have more than twice the odds of leaving AMA. These findings demonstrate that racial and socioeconomic disparities are important targets for future efforts to reduce AMA rates and improve outcomes from blunt and penetrating trauma. 相似文献
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《Reumatología clinica》2020,16(6):455-461
ObjectiveTo determinate the diagnostic value of an antibody against a citrullinated fibrinogen peptide in Cuban patients with rheumatoid arthritis, using an enzyme immunasay.Materials and methodsA citrullinated peptide of fibrinogen designed by informatics prediction was synthesized and used in an enzyme immunoassay. The participants were 81 patients with early disease, 81 patients with established disease, 58 patients with other rheumatic and inflammatory diseases, and 43 healthy individuals. Anti- citrullinated fibrinogen peptide, anti-mutated citrullinated vimentin, anti second generation citrullinated peptides and rheumatoid factor antibodies were determined by enzyme-linked immunosorbent assay.ResultsDetermination of anti-citrullinated peptide of fibrinogen antibodies by the designed enzyme immunoassay showed the best diagnostic value in early rheumatoid arthritis patients, with the highest value sensitivity (84%), negative predictive value (85%), Youden index (0.73%) and area under the receiver operating curve (0.9192). Specificity (89%) and positive predictive value (88%) were higher than rheumatoid factor, similar to anti- mutated citrullinated vimentin, but lower than second generation anti-citrullinated peptides assay. The positivity of C-reactive protein was associated with the presence of anti- citrullinated fibrinogen peptide antibodies and the titres of these antibodies correlated with clinical activity in early disease.ConclusionsThe immunoassay designed with a citrullinated fibrinogen peptide has a high diagnostic value and can identify patients with greater clinical activity in early rheumatoid arthritis. 相似文献
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Jessica S. Merlin Hailey W. Bulls Lee A. Vucovich E. Jennifer Edelman Joanna L. Starrels 《AIDS care》2016,28(12):1506-1515
Chronic pain occurs in as many as 85% of individuals with HIV and is associated with substantial functional impairment. Little guidance is available for HIV providers seeking to address their patients’ chronic pain. We conducted a systematic review to identify clinical trials and observational studies that examined the impact of pharmacologic or non-pharmacologic interventions on pain and/or functional outcomes among HIV-infected individuals with chronic pain in high-development countries. Eleven studies met inclusion criteria and were mostly low or very low quality. Seven examined pharmacologic interventions (gabapentin, pregabalin, capsaicin, analgesics including opioids) and four examined non-pharmacologic interventions (cognitive behavioral therapy, self-hypnosis, smoked cannabis). The only controlled studies with positive results were of capsaicin and cannabis, and had short-term follow-up (≤12 weeks). Among the seven studies of pharmacologic interventions, five had substantial pharmaceutical industry sponsorship. These findings highlight several important gaps in the HIV/chronic pain literature that require further research. 相似文献
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