Feasibility of a hybrid clinical trial for respiratory virus detection in toddlers during the influenza season.

BACKGROUND: Traditional clinical trials are conducted at investigator sites. Participants must visit healthcare facilities several times for the trial procedures. Decentralized clinical trials offer an interesting alternative. They use telemedicine and other technological solutions (apps, monitoring devices or web platforms) to decrease the number of visits to study sites, minimise the impact on daily routine, and decrease geographical barriers for participants. Not much information is available on the use of decentralization in randomized clinical trials with vaccines. METHODS: A hybrid clinical trial may be assisted by parental recording of symptoms using electronic log diaries in combination with home collected nasal swabs. During two influenza seasons, children aged 12 to 35 months with a history of recurrent acute respiratory infections were recruited in 12 primary health centers of the Valencia Region in Spain. Parents completed a symptom diary through an ad hoc mobile app that subsequently assessed whether it was an acute respiratory infection and requested collection of a nasal swab. Feasibility was measured using the percentage of returned electronic diaries and the validity of nasal swabs collected during the influenza season. Respiratory viruses were detected by real-time PCR. RESULTS: Ninety-nine toddlers were enrolled. Parents completed 10,476 electronic diaries out of the 10,804 requested (97%). The mobile app detected 188 potential acute respiratory infections (ARIs) and requested a nasal swab. In 173 (92%) ARI episodes a swab was taken. 165 (95.4%) of these swabs were collected at home and 144 (87.3%) of them were considered valid for laboratory testing. Overall, 152 (81%) of the ARIs detected in the study had its corresponding valid sample collected. CONCLUSIONS: Hybrid procedures used in this clinical trial with the influenza vaccine in toddlers were considered adequate, as we diagnosed most of the ARI cases on time, and had a valid swab in 81% of the cases. Hybrid clinical trials improve participant adherence to the study procedures and could improve recruitment and quality of life of the participants and the research team by decreasing the number of visits to the investigator site. This report emphasises that the conduct of hybrid CTs is a valid alternative to traditional CTs with vaccines. This hybrid CT achieved high adherence of participant to the study procedures. TRIAL REGISTRATION: 2019-001186-33 (EudraCT).

Asthma in older people hospitalized with influenza in Spain: A case-control study.

BACKGROUND: Influenza infection is an exacerbating factor for asthma, and its prevention is critical in older patients with asthma. OBJECTIVE: This study investigated the association between asthma and influenza-related hospitalization, in Spain, of patients ages ≥ 65 years and their clinical evolution. METHODS: A multicenter case-control study was carried out in 20 Spanish hospitals during the 2013-2014 and 2014-2015 influenza seasons. Patients ages ≥ 65 years hospitalized with laboratory-confirmed influenza with and without asthma were matched with controls according to the presence of asthma, sex, age, hospital, and date of hospitalization. RESULTS: A total of 561 patients with influenza (15.9% with asthma) and 1258 patients without influenza (8.0% with asthma) were included as cases and controls, respectively. The adjusted risk of influenza for patients with asthma was calculated by multivariate conditional logistic regression. The adjustment variables were the following: smoker/nonsmoker, pneumonia in the 2 years before hospital admission, previous oral treatment with corticosteroids, influenza vaccination during the seasonal campaign, Barthel index (ordinal scale used to measure performance in activities of daily living), level of education, obesity, and the presence of other comorbidities. Patients with asthma presented a great risk of influenza (adjusted odds ratio 2.64 [95% confidence interval, 1.77-3.94]). Compared with patients without asthma, patients with asthma had more symptoms, and these had been present for longer before admission but presented a lower hospital or postdischarge mortality. CONCLUSION: This study indicated that asthma was associated with hospitalization from influenza A infection. Although patients with asthma and with influenza had more symptoms, hospital or postdischarge mortality was lower, probably due to a better response to medical treatment.

Infrared thermography is useful for ruling out fractures in paediatric emergencies.

UNLABELLED: Musculoskeletal injuries are a leading cause of paediatric injuries and emergency department visits in Western countries. Diagnosis usually involves radiography, but this exposes children without fractures to unnecessary ionising radiation. We explored whether infrared thermography could provide a viable alternative in trauma cases. We compared radiography and thermal images of 133 children who had been diagnosed with a trauma injury in the emergency unit of a Spanish hospital. As well as the thermal variables in the literature, we introduced a new quantifier variable, the size of the lesion. Decision tree models were built to assess the technique's accuracy in diagnosing whether a bone had been fractured or not. Infrared thermography had a sensitivity of 0.91, a specificity of 0.88 and a negative predictive value of 0.95. The new lesion size variable introduced appeared to be of main importance to the discriminatory power of the method. CONCLUSION: The high negative predictive value of infrared thermography suggests that it is a promising method for ruling out fractures.

Infrared thermal imaging in the diagnosis of musculoskeletal injuries: a systematic review and meta-analysis.

OBJECTIVE: Musculoskeletal injuries occur frequently. Diagnostic tests using ionizing radiation can lead to problems for patients, and infrared thermal imaging could be useful when diagnosing these injuries. CONCLUSION: A systematic review was performed to determine the diagnostic accuracy of infrared thermal imaging in patients with musculoskeletal injuries. A meta-analysis of three studies evaluating stress fractures was performed and found a lack of support for the usefulness of infrared thermal imaging in musculoskeletal injuries diagnosis.

Geographical Variability in Mortality in Urban Areas: A Joint Analysis of 16 Causes of Death.

The geographical distribution of mortality has frequently been studied. Nevertheless, those studies often consider isolated causes of death. In this work, we aim to study the geographical distribution of mortality in urban areas, in particular, in 26 Spanish cities. We perform an overall study of 16 causes of death, considering that their geographical patterns could be dependent and estimating the dependence between the causes of death. We study the deaths in these 26 cities during the period 1996-2015 at the census tract level. A multivariate disease mapping model is used in order to solve the potential small area estimation problems that these data could show. We find that most of the geographical patterns found show positive correlations. This suggests the existence of a transversal geographical pattern, common to most causes of deaths, which determines those patterns to a higher/lower extent depending on each disease. The causes of death that exhibit that underlying pattern in a more prominent manner are chronic obstructive pulmonary disease (COPD), lung cancer, and cirrhosis for men and cardiovascular diseases and dementias for women. Such findings are quite consistent for most of the cities in the study. The high positive correlation found between geographical patterns reflects the existence of both high and low-risk areas in urban settings, in general terms for nearly all the causes of death. Moreover, the high-risk areas found often coincide with neighborhoods known for their high deprivation. Our results suggest that dependence among causes of death is a key aspect to be taken into account when mapping mortality, at least in urban contexts.

Changes in Socioeconomic Inequalities in Amenable Mortality after the Economic Crisis in Cities of the Spanish Mediterranean Coast.

Several studies have described a decreasing trend in amenable mortality, as well as the existence of socioeconomic inequalities that affect it. However, their evolution, particularly in small urban areas, has largely been overlooked. The aim of this study is to analyse the socioeconomic inequalities in amenable mortality in three cities of the Valencian Community, namely, Alicante, Castellon, and Valencia, as well as their evolution before and after the start of the economic crisis (2000-2007 and 2008-2015). The units of analysis have been the census tracts and a deprivation index has been calculated to classify them according to their level of socioeconomic deprivation. Deaths and population were also grouped by sex, age group, period, and five levels of deprivation. The specific rates by sex, age group, deprivation level, and period were calculated for the total number of deaths due to all causes and amenable mortality and Poisson regression models were adjusted in order to estimate the relative risk. This study confirms that the inequalities between areas of greater and lesser deprivation in both all-cause mortality and amenable mortality persisted along the two study periods in the three cities. It also shows that these inequalities appear with greater risk of death in the areas of greatest deprivation, although not uniformly. In general, the risks of death from all causes and amenable mortality have decreased significantly from one period to the other, although not in all the groups studied. The evolution of death risks from before the onset of the crisis to the period after presented, overall, a general pro-cyclical trend. However, there are population subgroups for which the trend was counter-cyclical. The use of the deprivation index has made it possible to identify specific geographical areas with vulnerable populations in all three cities and, at the same time, to identify the change in the level of deprivation (ascending or descending) of the geographical areas throughout the two periods. It is precisely these areas where more attention is needed in order to reduce inequalities.

Socioeconomic Inequalities in Mortality among Foreign-Born and Spanish-Born in Small Areas in Cities of the Mediterranean Coast in Spain, 2009-2015.

Many studies have analysed socioeconomic inequalities and its association with mortality in urban areas. However, few of them have differentiated between native and immigrant populations. This study is an ecological study of mortality by overall mortality and analyses the inequalities in mortality in these populations according to the level of deprivation in small areas of large cities in the Valencian Community, from 2009 to 2015. The census tract was classified into five deprivation levels using an index based on socioeconomic indicators from the 2011 census. Rates and relative risks of death were calculated by sex, age, level of deprivation and country of birth. Poisson regression models have been used. In general, there was a higher risk of death in natives at the levels of greatest deprivation, which did not happen in immigrants. During the 2009-2015 period, there were socioeconomic inequalities in mortality, particularly in natives, who presented a higher risk of death than immigrants. Future interventions and social policies should be implemented in order to reduce inequalities in mortality amongst socioeconomic levels and to maintain the advantage that the immigrant population enjoys.