Safety, Efficacy, and Immunogenicity of Therapeutic Vaccines for Patients with High-Grade Cervical Intraepithelial Neoplasia (CIN 2/3) Associated with Human Papillomavirus: A Systematic Review.

Despite the knowledge that HPV is responsible for high-grade CIN and cervical cancer, little is known about the use of therapeutic vaccines as a treatment. We aimed to synthesize and critically evaluate the evidence from clinical trials on the safety, efficacy, and immunogenicity of therapeutic vaccines in the treatment of patients with high-grade CIN associated with HPV. A systematic review of clinical trials adhering to the PRISMA 2020 statement in MEDLINE/PubMed, Embase, CENTRAL Cochrane, Web of Science, Scopus, and LILACS was undertaken, with no data or language restrictions. Primary endpoints related to the safety, efficacy, and immunogenicity of these vaccines were assessed by reviewing the adverse/toxic effects associated with the therapeutic vaccine administration via histopathological regression of the lesion and/or regression of the lesion size and via viral clearance and through the immunological response of individuals who received treatment compared to those who did not or before and after receiving the vaccine, respectively. A total of 1184 studies were identified, and 16 met all the criteria. Overall, the therapeutic vaccines were heterogeneous regarding their formulation, dose, intervention protocol, and routes of administration, making a meta-analysis unfeasible. In most studies (n = 15), the vaccines were safe and well tolerated, with clinical efficacy regarding the lesions and histopathological regression or viral clearance. In addition, eleven studies showed favorable immunological responses against HPV, and seven studies showed a positive correlation between immunogenicity and the clinical response, indicating promising results that should be further investigated. In summary, therapeutic vaccines, although urgently needed to avoid progression of CIN 2/3 patients, still present sparse data, requiring greater investments in a well-designed phase III RCT.

Nursing interventions to prevent corneal injury in critically ill sedated and mechanically ventilated patients: A systematic review of interventions.

OBJECTIVE: To identify the effectiveness of interventions to prevent corneal injury in critically ill, sedated, and mechanically ventilated patients. RESEARCH METHODOLOGY: A systematic review of intervention studies was conducted in the following electronic databases: Cumulative Index to Nursing and Allied Health Literature, Cochrane Central Register of Controlled Trials, Embase, Latin American and Caribbean Literature in Health Sciences, LIVIVO, PubMed, Scopus and Web of Science, and reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses. Study selection and data extraction were performed by two independent reviewers. Quality assessment of the randomized and non-randomized studies was performed using the Risk of Bias (RoB 2.0) and ROBINS-I Cochrane tools, respectively, and the Newcastle-Ottawa Scale for cohort studies. The certainty of the evidence was assessed according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system. RESULTS: 15 studies were included. Meta-analysis showed that the risk of corneal injury in the lubricants group was 66% lower (RR = 0.34; 95 %CI: 0.13-0.92) than in the eye-taping group. The risk of corneal injury in the polyethylene chamber was 68% lower than in the eye ointment group (RR = 0.32; 95 %CI 0.07-1.44). The risk of bias was low in most of the studies included and the certainty of the evidence was evaluated. CONCLUSIONS: The most effective interventions to prevent corneal injury in critically ill sedated mechanically ventilated, who have compromised blinking and eyelid closing mechanisms, are ocular lubrication, preferably gel or ointment, and protection of the corneas with a polyethylene chamber. IMPLICATIONS FOR CLINICAL PRACTICE: Critically ill, sedated, and mechanically ventilated patients who have compromised blinking and eyelid closing mechanisms must receive interventions to prevent corneal injury. Ocular lubrication, preferably gel or ointment, and protection of the corneas with a polyethylene chamber were the most effective interventions to prevent corneal injury in critically ill, sedated, and mechanically ventilated patients. A polyethylene chamber must be made commercially available for critically ill, sedated, and mechanically ventilated patients.

Effectiveness of interventions for the prevention of occupational violence against professionals in health services: a protocol for a systematic review.

INTRODUCTION: Occupational violence affects several categories of workers; however, the health sector category has been considered at a high risk, exposing workers to physical and psychological abuse. Thus, occupational violence has decreased the quality of care in health service. This review aims to evaluate the effectiveness of interventions for the prevention and reduction of occupational violence against health professionals. METHODS AND ANALYSIS: This protocol is consistent with the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols. Searches will be conducted in PubMed, Embase, Cochrane Library, LILACS, Web of Science, Scopus, CINAHL and LIVIVO along with a comprehensive review of grey literature. The search will be conducted on August 1 st 2020, without language and time restrictions. Following the eligibility criteria, two independent reviewers will select the titles and abstracts and subsequently screen the full articles. If necessary, a third reviewer will assess any disagreements. All references will be imported into EndNote, and any duplicates will be removed. The data will be extracted using an extraction-based form from Cochrane. Statistical analyses will be performed using the software Cochrane Review Manager, and a meta-analysis will be performed if possible for the statistical combination of at least two studies. The risk of bias of the randomised clinical trials will be evaluated by the Risk of Bias tool from Cochrane, and the risk of bias of the non-randomised intervention studies will be evaluated using the Downs and Black scale. The quality of the evidence and strength of the classification recommendations will be assessed by the Grading of Recommendations, Assessment, Development and Evaluation. ETHICS AND DISSEMINATION: This review will not evaluate individual patient information and therefore does not require ethical approval. The results will be disseminated through publications in peer-reviewed journals, presentations at conferences and the doctoral thesis of the leading author. PROSPERO REGISTRATION NUMBER: CRD42018111383.

Durometry as an alternative tool to the modified Rodnan's skin score in the assessment of diffuse systemic sclerosis patients: a cross-sectional study.

BACKGROUND: The reproducibility and reliability of the modified Rodnan's Skin Score (mRSS) are debated due to investigator-related subjectivity. Here, we evaluate if durometry correlates with mRSS in patients with diffuse systemic sclerosis (SSc). METHODS: This cross-sectional study was conducted from December 2018 to June 2019, including 58 diffuse SSc patients. Two certified researchers, blind to each other's scores, performed the mRSS, followed by durometry at 17 predefined skin sites. For durometry and mRSS, individual scores per skin site were registered. Durometry and mRSS results measured by each researcher, as well as scores from different researchers, were compared. Skin thickness measurements from forearm skin biopsies were available in a subset of the patients, for comparisons. Statistical analyses included Cohen's Kappa Coefficient, Intraclass Correlation Coefficient, Kendall's Coefficient and Spearman's test. RESULTS: Mean (standard deviation, SD) patient age was 44.8 (12.9) years, and 88% were female. Inter-rater agreement varied from 0.88 to 0.99 (Intraclass correlation coefficient) for durometry, and 0.54 to 0.79 (Cohen's Kappa coefficient) for mRSS, according to the specific evaluated sites. When data were compared with skin thickness assessed in forearm biopsies, durometry correlated better with skin thickness than mRSS. CONCLUSION: Durometry may be considered as an alternative method to quantify skin involvement in patients with diffuse SSc. The strong inter-rater agreement suggests that the method may be useful for the assessment of patients by multiple researchers, as in clinical trials.

Durometry as an alternative tool to the modified Rodnans skin score in the assessment of diffuse systemic sclerosis patients: a cross-sectional study

Abstract Background The reproducibility and reliability of the modified Rodnan's Skin Score (mRSS) are debated due to investigator-related subjectivity. Here, we evaluate if durometry correlates with mRSS in patients with diffuse systemic sclerosis (SSc). Methods This cross-sectional study was conducted from December 2018 to June 2019, including 58 diffuse SSc patients. Two certified researchers, blind to each other's scores, performed the mRSS, followed by durometry at 17 predefined skin sites. For durometry and mRSS, individual scores per skin site were registered. Durometry and mRSS results measured by each researcher, as well as scores from different researchers, were compared. Skin thickness measurements from forearm skin biopsies were available in a subset of the patients, for comparisons. Statistical analyses included Cohen's Kappa Coefficient, Intraclass Correlation Coefficient, Kendall's Coefficient and Spearman's test. Results Mean (standard deviation, SD) patient age was 44.8 (12.9) years, and 88% were female. Inter-rater agreement varied from 0.88 to 0.99 (Intraclass correlation coefficient) for durometry, and 0.54 to 0.79 (Cohen's Kappa coefficient) for mRSS, according to the specific evaluated sites. When data were compared with skin thickness assessed in forearm biopsies, durometry correlated better with skin thickness than mRSS. Conclusion Durometry may be considered as an alternative method to quantify skin involvement in patients with diffuse SSc. The strong inter-rater agreement suggests that the method may be useful for the assessment of patients by multiple researchers, as in clinical trials.(AU)

Motivo de retirada do cateter de Hickman em pacientes submetidos ao transplante de células-tronco hematopoéticas / Rationale for Hickman catheter removal in patients undergoing hematopoietic stem cell transplantation / Motivo del retiro del catéter de Hickman en pacientes sometidos al transplante de células-tronco hematopoéticas

OBJETIVO: Identificar os motivos da retirada do primeiro cateter de Hickman implantado em pacientes submetidos ao transplante de células-tronco hematopoéticas alogênico, os micro-organismos envolvidos na ocorrência de infecção e o tempo de permanência do cateter in situ. MÉTODOS: Estudo transversal retrospectivo. A amostra foi constituída por 57 prontuários de pacientes transplantados. Para a obtenção dos dados, elaborou-se um instrumento contendo variáveis relativas à identificação do paciente, tempo de permanência do cateter, motivo de retirada e micro-organismo isolado. RESULTADOS: Dentre os motivos de retirada do cateter, destacou-se como o mais frequente a infecção (49 por cento). O Stenotrophomonas maltophilia (25 por cento) foi o micro-organismo identificado com maior frequência. CONCLUSÕES: Diante da elevada incidência de complicações infecciosas que levam à retirada do cateter de Hickman, faz-se necessária uma padronização de cuidados relacionados a esse cateter, tanto para a equipe de saúde como ao paciente e seu cuidador.

OBJECTIVE: To identify rationale for removal of the first Hickman catheter implanted in patients undergoing allogeneic hematopoietic stem cell transplantation, the micro-organisms involved in the occurrence of infection, and the length of time the catheter was in situ. METHODS: A cross sectional, retrospective study was conducted. The sample consisted of 57 transplant recipients. To conduct chart review, an instrument was developed containing variables related to patient identification, time of catheter use, reason for withdrawal, and isolated micro-organisms. RESULTS: Among the reasons for catheter removal, frequent infection (49 percent) was the most common; the Stenotrophomonas maltophilia microorganism (25 percent) was the most frequently isolated. CONCLUSIONS: Due to the high incidence of infectious complications leading to Hickman catheter removal, it is essential to standardize catheter care for the health care team, patients and their caregivers.

OBJETIVO: Identificar los motivos del retiro del primer catéter de Hickman implantado en pacientes sometidos al transplante de células-tronco hematopoéticas alogénico, los microorganismos involucrados en la ocurrencia de infección y el tiempo de permanencia del catéter in situ. MÉTODOS: Estudio transversal retrospectivo. La muestra estuvo constituída por 57 historias clínicas de pacientes transplantados. Para la obtención de los datos, se elaboró un instrumento conteniendo variables relativas a la identificación del paciente, tiempo de permanencia del catéter, motivo del retiro y microorganismo aislado. RESULTADOS: Entre los motivos del retiro del catéter, se destacó como el más frecuente la infección (49 por ciento). El Stenotrophomonas maltophilia (25 por ciento) fue el microorganismo identificado con mayor frecuencia. CONCLUSIONES: Frente a la elevada incidencia de complicaciones infecciosas que llevan al retiro del catéter de Hickman, se hace necesaria una patronización de cuidados relacionados a ese catéter, tanto para el equipo de salud como para el paciente y su cuidador.