Approaches to prioritising research for clinical trial networks: a scoping review.

BACKGROUND: Prioritisation of clinical trials ensures that the research conducted meets the needs of stakeholders, makes the best use of resources and avoids duplication. The aim of this review was to identify and critically appraise approaches to research prioritisation applicable to clinical trials, to inform best practice guidelines for clinical trial networks and funders. METHODS: A scoping review of English-language published literature and research organisation websites (January 2000 to January 2020) was undertaken to identify primary studies, approaches and criteria for research prioritisation. Data were extracted and tabulated, and a narrative synthesis was employed. RESULTS: Seventy-eight primary studies and 18 websites were included. The majority of research prioritisation occurred in oncology and neurology disciplines. The main reasons for prioritisation were to address a knowledge gap (51 of 78 studies [65%]) and to define patient-important topics (28 studies, [35%]). In addition, research organisations prioritised in order to support their institution's mission, invest strategically, and identify best return on investment. Fifty-seven of 78 (73%) studies used interpretative prioritisation approaches (including Delphi surveys, James Lind Alliance and consensus workshops); six studies used quantitative approaches (8%) such as prospective payback or value of information (VOI) analyses; and 14 studies used blended approaches (18%) such as nominal group technique and Child Health Nutritional Research Initiative. Main criteria for prioritisation included relevance, appropriateness, significance, feasibility and cost-effectiveness. CONCLUSION: Current research prioritisation approaches for groups conducting and funding clinical trials are largely interpretative. There is an opportunity to improve the transparency of prioritisation through the inclusion of quantitative approaches.

Epidemiological situation of yaws in the Americas: A systematic review in the context of a regional elimination goal.

BACKGROUND: Yaws is targeted for eradication by 2020 in the WHA66.12 resolution of the World Health Assembly. The objective of this study was to describe the occurrence of yaws in the Americas and to contribute to the compilation of evidence based on published data to undertake the certification of yaws eradication. METHODOLOGY: A systematic review of the epidemiological situation of yaws in the Americas was performed by searching in MEDLINE, Embase, LILACS, SCOPUS, Web of Science, DARE and Cochrane Database of Systematic Reviews. Experts on the topic were consulted, and institutional WHO/PAHO library databases were reviewed. PRINCIPAL FINDINGS: Seventy-five full-text articles published between 1839 and 2012 met the inclusion criteria. Haiti and Jamaica were the two countries with the highest number of papers (14.7% and 12.0%, respectively). Three-quarters of the studies were conducted before 1970. Thirty-three countries reported yaws case count or prevalence data. The largest foci in the history were described in Brazil and Haiti. The most recent cases reported were recorded in eight countries: Suriname, Guyana, Colombia, Haiti, Martinique, Dominica, Trinidad and Tobago, and Brazil. Gaps in information and heterogeneity were detected in the methodologies used and outcome reporting, making cross-national and chronological comparisons difficult. CONCLUSIONS: The lack of recent yaws publications may reflect, in the best-case scenario, the interruption of yaws transmission. It should be possible to reach the eradication goal in the region of the Americas, but it is necessary to collect more information. We suggest updating the epidemiological status of yaws, especially in two countries that need to assess ongoing transmission. Twenty-four countries need to demonstrate the interruption of transmission and declare its status of yaws endemicity, and sixteen countries should declare if they are yaws-free. It is necessary to formally verify the achievement of this goal in Ecuador.

Injuries Among Immigrants Treated in Primary Care in Madrid, Spain.

This study compared the injury incidence rates by sex in adult immigrant and native population attended in primary care in the Community of Madrid, Spain. Cross-sectional study of injuries registered in the primary care electronic medical record in 2012. Crude and age-adjusted incidence rates by sex, region of birth and type of injury were calculated. Poisson regression was performed. In both sexes, the highest crude injury incidence rate was found in immigrants from North Africa, followed by the native population. After controlling for age and socioeconomic-status, the highest risk of injury in immigrants was observed in burns in women from North-African (79%) and in foreign body injuries in men from Latin America and Caribbean, Sub-Saharan and North Africa and Central and Eastern Europe (61-123%). The analysis by region of origin has identified people from North Africa as a particularly vulnerable group.

Design and validation of an oral health questionnaire for preoperative anaesthetic evaluation / Projeto e validação de um questionário de saúde oral para avaliação pré-anestésica no pré-operatório

Abstract Background and objectives: Dental injuries incurred during endotracheal intubation are more frequent in patients with previous oral pathology. The study objectives were to develop an oral health questionnaire for preanaesthesia evaluation, easy to apply for personnel without special dental training; and establish a cut-off value for detecting persons with poor oral health. Methods: Validation study of a self-administered questionnaire, designed according to a literature review and an expert group's recommendations. The questionnaire was applied to a sample of patients evaluated in a preanaesthesia consultation. Rasch analysis of the questionnaire psychometric properties included viability, acceptability, content validity and reliability of the scale. Results: The sample included 115 individuals, 50.4% of men, with a median age of 58 years (range: 38-71). The final analysis of 11 items presented a Person Separation Index of 0.861 and good adjustment of data to the Rasch model. The scale was unidimensional and its items were not biased by sex, age or nationality. The oral health linear measure presented good construct validity. The cut-off value was set at 52 points. Conclusions: The questionnaire showed sufficient psychometric properties to be considered a reliable tool, valid for measuring the state of oral health in preoperative anaesthetic evaluations.

Resumo Justificativa e objetivo: As lesões dentárias que ocorrem durante a intubação traqueal são mais frequentes em pacientes com patologia oral prévia. O objetivo do estudo foi desenvolver um questionário de saúde bucal para avaliação no período pré-anestesia, de fácil aplicação por pessoal sem formação odontológica, e estabelecer um valor de corte para detectar pessoas com má saúde bucal. Métodos: Estudo de validação de um questionário autoadministrado, projetado de acordo com uma revisão da literatura e recomendações de um grupo de especialistas. O questionário foi aplicado a uma amostra de pacientes avaliados em uma consulta pré-anestesia. A análise Rasch das propriedades psicométricas do questionário incluiu viabilidade, aceitabilidade, validade de conteúdo e confiabilidade da escala. Resultados: A amostra incluiu 115 indivíduos, 50,4% de homens, com mediana de 58 anos (variação: 38-71). A análise final dos 11 itens apresentou um índice de separação dos indivíduos de 0,861 e um bom ajuste dos dados ao modelo de Rasch. A escala foi unidimensional e seus itens não foram influenciados por sexo, idade ou nacionalidade. A medida linear da saúde bucal apresentou boa validade de constructo. O valor de corte foi fixado em 52 pontos. Conclusões: O questionário mostrou propriedades psicométricas suficientes para ser considerado uma ferramenta confiável, válida para medir o estado de saúde bucal nas avaliações pré-anestesia antes da operação.

Socioeconomic inequalities in injuries treated in primary care in Madrid, Spain.

Background: Socioeconomic inequalities in injury morbidity are an important yet understudied issue in Southern Europe. This study analysed the injuries treated in primary care in the Community of Madrid, Spain, by socioeconomic status (SES), sex and age. Methods: This was a cross-sectional study of injuries registered in the primary care electronic medical records of the Madrid Health Service in 2012. Incidence stratified by sex, SES and type of injury were calculated. Poisson regression was performed. Results: A statistically significant upward trend in global injury incidence was observed with decreasing SES in all age groups. By type of injury, the largest differences were observed in injuries by foreign body in men aged 15-44 and in poisonings in girls under 15 years of age. Burns risk also stood out in the group of girls under 15 years of age with the lowest SES. In the group above 74 years of age, wounds, bruises and sprains had the lowest SES differences in both sexes, and the risk of fractures was lower in the most socioeconomically advantaged group. Conclusion: People with lower SES were at a greater risk of injury. The relationship between SES and injury varies by type of injury and age.

[Design and validation of an oral health questionnaire for preoperative anaesthetic evaluation]. / Projeto e validação de um questionário de saúde oral para avaliação pré­anestésica no pré­operatório.

BACKGROUND AND OBJECTIVES: Dental injuries incurred during endotracheal intubation are more frequent in patients with previous oral pathology. The study objectives were to develop an oral health questionnaire for preanaesthesia evaluation, easy to apply for personnel without special dental training; and establish a cut-off value for detecting persons with poor oral health. METHODS: Validation study of a self-administered questionnaire, designed according to a literature review and an expert group's recommendations. The questionnaire was applied to a sample of patients evaluated in a preanaesthesia consultation. Rasch analysis of the questionnaire psychometric properties included viability, acceptability, content validity and reliability of the scale. RESULTS: The sample included 115 individuals, 50.4% of men, with a median age of 58 years (range: 38-71). The final analysis of 11 items presented a Person Separation Index of 0.861 and good adjustment of data to the Rasch model. The scale was unidimensional and its items were not biased by sex, age or nationality. The oral health linear measure presented good construct validity. The cut-off value was set at 52 points. CONCLUSIONS: The questionnaire showed sufficient psychometric properties to be considered a reliable tool, valid for measuring the state of oral health in preoperative anaesthetic evaluations.

Design and validation of an oral health questionnaire for preoperative anaesthetic evaluation.

BACKGROUND AND OBJECTIVES: Dental injuries incurred during endotracheal intubation are more frequent in patients with previous oral pathology. The study objectives were to develop an oral health questionnaire for preanaesthesia evaluation, easy to apply for personnel without special dental training; and establish a cut-off value for detecting persons with poor oral health. METHODS: Validation study of a self-administered questionnaire, designed according to a literature review and an expert group's recommendations. The questionnaire was applied to a sample of patients evaluated in a preanaesthesia consultation. Rasch analysis of the questionnaire psychometric properties included viability, acceptability, content validity and reliability of the scale. RESULTS: The sample included 115 individuals, 50.4% of men, with a median age of 58 years (range: 38-71). The final analysis of 11 items presented a Person Separation Index of 0.861 and good adjustment of data to the Rasch model. The scale was unidimensional and its items were not biased by sex, age or nationality. The oral health linear measure presented good construct validity. The cut-off value was set at 52 points. CONCLUSIONS: The questionnaire showed sufficient psychometric properties to be considered a reliable tool, valid for measuring the state of oral health in preoperative anaesthetic evaluations.

Effects of annual influenza vaccination on mortality in patients with heart failure.

The objective was to evaluate the effect of influenza vaccine on all-cause mortality in a cohort of patients with heart failure followed up in primary care centres of the Community of Madrid, Spain, during the period 2006-10. Results of the Cox proportional-hazard model were adjusted for age and sex and, after 1:1 nearest neighbour matching, for propensity score. The analysis was further stratified by season. Having received annual influenza vaccine was associated with a decreased risk of death during the influenza season (hazard ratio = 0.59, 95% CI = 0.41-0.84), but no protective effect was observed before or after the influenza season.

Prevalence and prognostic impact of frailty and its components in non-dependent elderly patients with heart failure.

AIMS: The aim of this study was to evaluate the prevalence, clinical features, and the independent impact of frailty-a geriatric syndrome characterized by the decline of physiological systems-and its components, on prognosis after heart failure (HF) hospitalization. METHODS AND RESULTS: FRAIL-HF is a prospective cohort study including 450 non-dependent patients ≥70 years old hospitalized for HF. Frailty was screened according to the biological phenotype criteria (low physical activity, weight loss, slow walking speed, weak grip strength, and exhaustion). The independent influence of frailty on mortality, functional decline, and readmission risks was calculated adjusted for HF characteristics and co-morbidities. Mean age was 80 ± 6 years; 76% fulfilled frailty criteria. Frail patients were older, more often female, but showed no differences in chronic co-morbidities, LVEF, and NT-proBNP levels. Slow walking speed was the most discriminative component between frail (89.2%) and non-frail patients (26%). Overall, 1-year survival was 89% in the non-frail group and 75% in frail subjects (P = 0.003). After adjusting for age, gender, chronic and acute co-morbidities, NYHA, and NT-proBNP, frail patients showed higher risks for 30-day functional decline [odds ratio (OR) 2.20, 95% confidence interval (CI) 1.19-4.08], 1-year all-cause mortality [hazard ratio (HR) 2.13, 95% CI 1.07-4.23], and 1-year readmission (OR 1.96, 95% CI 1.14-3.34). The association of individual components with 1-year adjusted mortality risk was HR 2.14, 95% CI 1.05-4.39 for low physical activity and HR 1.77, 95% CI 0.95-3.29 for slow walking speed. CONCLUSION: Frailty is highly prevalent even among non-dependent elderly HF patients, and is an independent predictor of early disability, long-term mortality, and readmission. Individual frailty components may be useful for risk prediction.

Dealing with Ebola virus disease in Spain: epidemiological inquiries received by the Department of Public Health Alerts, April to December 2014.

We describe the inquiries regarding Ebola virus disease (EVD) received by the Department of Public Health Alerts of the Community of Madrid between April and December 2014. A total of 242 inquiries were received. Consultations were initiated most frequently by hospital clinicians (59 inquiries, 24%), private citizens (57 inquiries, 24%) and primary care physicians (53 inquiries, 22%). The most frequent topic of inquiry was possible EVD in a patient (215 inquiries, 89%). Among these, 31 persons (14%) presented both EVD-compatible symptoms and epidemiological risk factors, and 11 persons (5%) fulfilled the criteria for a person under investigation. Recent travel abroad was reported in 96 persons (45%), but only 32 (15%) had travelled to an EVD-affected area. Two high-risk and one low-risk contact were identified through these inquiries. Low specificity of the EVD symptoms led to many difficulties in protocol application. Ineffective communication with healthcare professionals and unfamiliarity with the EVD protocols caused many case classification errors. A rapid consultation service by telephone is essential for providing qualified advice during emergencies. Our experience may help other countries dimension their activities and resources for managing similar exceptional outbreaks in the future.

Quality of life across three groups of older adults differing in cognitive status and place of residence.

BACKGROUND: Health-related quality of life (HRQOL) in older adults is determined by personal conditions, as well as by the social and physical environment. The purpose of the present study was to describe the factors related to health conditions and residential environment that influence HRQOL of older adults. METHODS: Data from 1815 cases came from three cross-sectional surveys on quality of life in older adults in Spain: non-institutionalized older adults (n = 1106), institutionalized older adults without dementia (n = 234) and institutionalized older adults with dementia (n = 475). Assessment instruments used were: Barthel Index, Short Portable Mental Status Questionnaire, Comorbidity Index, EQ-5D-3L (5 dimensions, EQ-index and EQ-VAS), and information about sociodemographic characteristics and social networks. Partial correlation and multivariate logistic regression analyses were carried out. RESULTS: In group comparisons, institutionalized older adults showed a higher percentage of problems in the EQ-5D-3L dimensions than the non-institutionalized ones. Also, older adults with dementia presented less pain/discomfort and anxiety/depression than the other groups, but showed more problems in mobility, self-care and usual activities. EQ-Index showed a high association with functional independence, perceived health status and comorbidity. According to the logistic regression models, the Barthel Index was the most common determinant for most of EQ-5D-3L dimensions in all groups. CONCLUSION: Institutionalized older adults with dementia presented lower HRQOL than the other groups. Functional independence, comorbidity and cognitive status were the main HRQOL determinants in all groups. Maintenance and improvement of the functional condition might be translated into a higher HRQOL of older adults.

The role of high-risk human papillomavirus infection in oral and oropharyngeal squamous cell carcinoma in non-smoking and non-drinking patients: a clinicopathological and molecular study of 46 cases.

The aim of the study was to investigate the role of high-risk human papillomavirus (HR-HPV) infection in the etiopathogenesis of oral (OSCC) and oropharyngeal (OPSCC) squamous cell carcinoma in non-smoking and non-drinking patients (NSNDP). Twenty-four OSCCs and 22 OPSCCs were analyzed by immunohistochemistry for p16(INK4a) protein (p16) expression and by chromogene in situ hybridization (CISH) and polymerase chain reaction (PCR) for HR-HPV DNA presence. The series included 23 males and 23 females aged 35-93 years. p16 expression was seen in 7 out of 24 (29%) OSCCs and in 22 out of 22 (100%) OPSCCs. Using CISH, HR-HPV DNA was observed in 6 out of 24 (25%) OSCCs and in 21 out of 22 (95%) OPSCCs. HPV DNA was found in 3 out of 24 (13%) OSCCs and in 18 out of 22 (82%) OPSCCs using PCR. HPV 16 and 33 were detected in 16 and in two cases, respectively. Compared with OSCCs, OPSCCs more frequently showed basaloid morphology (p < 0.0001), lymph node involvement (p = 0.0063), diffuse p16 expression (p < 0.0001), HR-HPV DNA presence using both CISH and PCR (p < 0.0001; p < 0.0001), and better outcome. The sensitivity and specificity of p16 expression for HR-HPV DNA presence detected by CISH were 0.89 and 0.95, respectively, and 0.95 and 0.85 for PCR detected HPV DNA. The sensitivity and specificity of CISH for PCR detected presence of HPV DNA were 1.00 and 0.73, respectively. Our study is the first larger study analyzing OSCC and OPSCC in NSNDP. Our results indicate that unlike OSCC, a vast majority of OPSCCs may be associated with HR-HPV infection.

Expression profiles of viral responsive genes in oral and oropharyngeal cancers.

The association between Human Papillomavirus (HPV) DNA and oropharyngeal squamous cell carcinoma (SCC) has been supported by numerous studies strongly implicating HPV infection as a factor in the development of this cancer. In contrast, squamous cell carcinoma of the oral cavity has not been associated with HPV DNA, suggesting alternate aetiologic factors. The possibility that viral agents other than HPV could contribute to the development of oral cavity SCC should be given consideration, especially given the association of Epstein-Barr virus (EBV) with nasopharyngeal cancer. We used quantitative polymerase chain reaction (qPCR) studies to compare the expression levels of genes that may act as indicators of persistent stimulation by viral antigen in both oral cavity and oropharyngeal squamous cell cancers. Our results demonstrate that HPV-positive oropharyngeal tumours displayed gene expression patterns indicative of a viral signature and that HPV-negative oropharyngeal tumours do not display similar expression patterns. In contrast, we saw no evidence of either a viral or bacterial signature in the oral tumours examined. This would suggest that either an as of yet unidentified virus present in the oral tumour samples is not eliciting a typical immune response, or that there are no novel viral sequences or viruses present in the oral tumours examined.

Effect of low dose of vinclozolin on reproductive tract development and sperm parameters in CD1 outbred mice.

The effect of a low dose of vinclozolin within the development of the reproductive tract during gestation (VIN-GD 15-22) and puberty (VIN-PND 23-44) in CD1 mice was tested. We found a decrease in the anogenital distance, prostate weight and pathology of testes in both experimental groups. Sperm counts decreased to 46% (VIN-GD) and to 81% (VIN-PND), and also the acrosomal state (evaluated by antiacrosomal antibody) decreased in both groups to 89% in comparison to the control group (100%). Sperm head abnormalities increased by approximately 18% and 13%, respectively. In this connection, the expression of some genes was changed (arosome-related gene (Acr), apoptosis related genes (p53, p21)). In conclusion, a low dose of vinclozolin affected the reproductive tract, sperm parameters and expression of selected genes in both experimental groups.