Impact of COVID-19 pandemic on the PREDIMED-Plus randomized clinical trial: Effects on the interventions, participants follow-up, and adiposity.

Background: The COVID-19 pandemic has affected the implementation of most ongoing clinical trials worldwide including the PREDIMED-Plus study. The PREDIMED-Plus is an ongoing, multicenter, controlled intervention trial, aimed at weight-loss and cardiovascular disease prevention, in which participants were randomized (1:1 ratio) to an intervention group (energy-reduced Mediterranean diet, promotion of physical activity, and behavioral support) or to a control group (Mediterranean diet with usual care advice). When the pandemic began, the trial was in the midst of the planned intervention. The objective of this report was to examine the effects of the pandemic on the delivery of the intervention and to describe the strategies established to mitigate the possible adverse effects of the pandemic lockdown on data collection and adiposity. Methods: We assessed the integrity of the PREDIMED-Plus trial during 5 identified periods of the COVID-19 pandemic determined according to restrictions dictated by the Spanish government authorities. A standardized questionnaire was delivered to each of the 23 PREDIMED-Plus recruiting centers to collected data regarding the trial integrity. The effect of the restrictions on intervention components (diet, physical activity) was evaluated with data obtained in the three identified lockdown phases: pre lockdown, lockdown proper, and post lockdown. Results: During the lockdown (March/2020-June/2021), 4,612 participants (48% women, mean age 65y) attended pre-specified yearly follow-up visits to receive lifestyle recommendations and obtain adiposity measures. The overall mean (SD) of the proportions reported by each center showed that 40.4% (25.4) participants had in-person visits, 39.8% (18.2) participants were contacted by telephone and 35% (26.3) by electronic means. Participants' follow-up and data collection rates increased across lockdown periods (from ≈10% at onset to ≈80% at the end). Compared to pre-lockdown, waist circumference increased during (0.75 cm [95% CI: 0.60-0.91]) and after (0.72 cm [95% CI: 0.56-0.89]) lockdown. Body weight did not change during lockdown (0.01 kg [95% CI: -0.10 to 0.13) and decreased after lockdown (-0.17 kg [95% CI: -0.30 to -0.04]). Conclusion: Mitigating strategies to enforce the intervention and patient's follow-up during lockdown have been successful in preserving the integrity of the trial and ensuring its continuation, with minor effects on adiposity. Clinical trial registration: https://doi.org/10.1186/ISRCTN89898870, identifier ISRCTN89898870.

Impact of COVID-19 pandemic on the PREDIMED-Plus randomized clinical trial: Effects on the interventions, participants follow-up, and adiposity

Background The COVID-19 pandemic has affected the implementation of most ongoing clinical trials worldwide including the PREDIMED-Plus study. The PREDIMED-Plus is an ongoing, multicenter, controlled intervention trial, aimed at weight-loss and cardiovascular disease prevention, in which participants were randomized (1:1 ratio) to an intervention group (energy-reduced Mediterranean diet, promotion of physical activity, and behavioral support) or to a control group (Mediterranean diet with usual care advice). When the pandemic began, the trial was in the midst of the planned intervention. The objective of this report was to examine the effects of the pandemic on the delivery of the intervention and to describe the strategies established to mitigate the possible adverse effects of the pandemic lockdown on data collection and adiposity. Methods We assessed the integrity of the PREDIMED-Plus trial during 5 identified periods of the COVID-19 pandemic determined according to restrictions dictated by the Spanish government authorities. A standardized questionnaire was delivered to each of the 23 PREDIMED-Plus recruiting centers to collected data regarding the trial integrity. The effect of the restrictions on intervention components (diet, physical activity) was evaluated with data obtained in the three identified lockdown phases: pre lockdown, lockdown proper, and post lockdown. Results During the lockdown (March/2020-June/2021), 4,612 participants (48% women, mean age 65y) attended pre-specified yearly follow-up visits to receive lifestyle recommendations and obtain adiposity measures. The overall mean (SD) of the proportions reported by each center showed that 40.4% (25.4) participants had in-person visits, 39.8% (18.2) participants were contacted by telephone and 35% (26.3) by electronic means. Participants' follow-up and data collection rates increased across lockdown periods (from ≈10% at onset to ≈80% at the end). Compared to pre-lockdown, waist circumference increased during (0.75 cm [95% CI: 0.60–0.91]) and after (0.72 cm [95% CI: 0.56–0.89]) lockdown. Body weight did not change during lockdown (0.01 kg [95% CI: –0.10 to 0.13) and decreased after lockdown (-0.17 kg [95% CI: –0.30 to –0.04]). Conclusion Mitigating strategies to enforce the intervention and patient's follow-up during lockdown have been successful in preserving the integrity of the trial and ensuring its continuation, with minor effects on adiposity. Clinical trial registration https://doi.org/10.1186/ISRCTN89898870, identifier ISRCTN89898870.

Tasas de letalidad por SARS-CoV-2 durante la segunda onda epidémica en España según Comunidades Autónomas Case-fatality rates of SARS-CoV-2 infection according to Autonomous Communities during the second epidemic wave in Spain

Introducción: En España, los sistemas sanitarios están transferidos a las Comunidades Autónomas (CC.AA.), constituyendo 19 sistemas sanitarios con gestión y recursos diferenciados. Durante la primera onda epidémica del COVID-19 se objetivaron diferencias en los sistemas de declaración y en las tasas de letalidad (TL) entre las CC.AA. El objetivo de este estudio fue analizar las TL por CC.AA. durante la segunda onda epidémica (del 20 de julio al 25 de diciembre de 2020) y su relación con la prevalencia de la infección. Material y métodos: Se realizó un estudio observacional descriptivo con la información disponible sobre el número de fallecidos por COVID-19 registrados en el Ministerio de Sanidad, Consejerías de Salud y los Departamentos de Salud Pública de las CC.AA. y según el exceso de mortalidad informado por el Sistema de Monitorización de Mortalidad Diaria (MoMo). La prevalencia de la infección se estimó a partir de las diferencias entre la segunda y cuarta ronda del estudio ENE-COVID y sus intervalos de confianza del 95%. Se calcularon las TL (fallecidos por cada mil infectados) globales, por sexo, grupos de edad (< 65 y ≥ 65 años) y CC.AA. Se calculó la Razón Estandarizada de Letalidad por edad (REL) de las CC.AA. utilizando las TL de España para cada grupo de etario. Estas estimaciones se realizaron con las defunciones declaradas oficialmente (TLo) y el exceso de defunciones estimadas por MoMo (TLMo). Se estimaron las correlaciones entre las prevalencias de infección y las TLo y TLMo, ponderando por población. Resultados: Para el conjunto de España, la TLo durante la segunda onda epidémica fue del 7,6‰, oscilando entre 3,8‰ de Baleares y 16,4‰ de Asturias, y la TLMo fue de 10,1‰, oscilando entre el 4,8‰ de Madrid y el 21,7‰ en Asturias. Se observaron diferencias significativas entre la TLo y la TLMo en Canarias, Castilla la Mancha, Extremadura, Comunidad Valenciana, Andalucía y las Ciudades Autónomas de Ceuta y Melilla. La TLo fue significativamente mayor en hombres (8,2‰) que en mujeres (7,1‰). Las TLo y TLMo fueron significativamente mayores en el grupo de edad ≥65 años (55,4‰ y 72,2‰ respectivamente) que en el grupo <65 años (0,5‰ y 1,4‰ respectivamente). País Vasco, Aragón, Andalucía y Castilla la Mancha presentaron una REL significativamente superiores a uno. Las correlaciones entre la prevalencia de infección y las TLo fueron inversas. Conclusiones: La letalidad por COVID-19 durante la segunda onda epidémica en España mejoró respecto a la primera. Los datos disponibles sugieren que la letalidad de la segunda onda en las CC.AA. estaría influida por la elevada letalidad observada en la primera onda en personas con comorbilidades, así como por las limitaciones de los sistemas de detección y notificación de SARS-CoV-2. Las tasas de letalidad fueron mayores en hombres y personas mayores, y variaban significativamente entre CC.AA. Es necesario profundizar en el análisis de las causas de estas diferencias.

Role of Rapid Antigen Testing in Population-Based SARS-CoV-2 Screening.

This study evaluates a population-based screening of asymptomatic people, using a rapid antigen diagnostic test (RADT), in areas of high transmission. To detect sources of SARS-CoV-2 infection, nasopharyngeal samples were taken and were tested using RADT. Confirmatory RT-qPCR tests were performed in both positive and negative cases. The internal validity of the RADT, the prevalence of infection, and the positive and negative predictive values (PPV and NPV) were estimated, based on the percentages of confirmed cases with 95% confidence interval. Of the 157,920 people registered, 50,492 participated in the screening; 50,052 were negative, and 440 were positive on the RADT (0.87%). A total of 221 positive RADT samples were reanalysed using RT-qPCR and 214 were confirmed as positive (96.8%; 95% CI: 93.5-98.7%), while 657 out of 660 negative RADT samples were confirmed as RT-qPCR negative (99.5%; 95% CI 98.7-99.9%). The sensitivity obtained was 65.1% (38.4-90.2%) and the specificity was 99.97% (99.94-99.99%). The prevalence of infection was 1.30% (0.95-2.13%). The PPVs were 95.4% (85.9-98.9%) and 97.9% (93.3-99.5%), respectively, while the NPVs were 99.7% (99.4-100%) and 99.2% (98.7-100%), respectively. The high specificity found allow us to report a high screening performance in asymptomatic patients, even in areas where the prevalence of infection was less than 2%.