REDCapDM: An R package with a set of data management tools for a REDCap project.

BACKGROUND: Research Electronic Data CAPture (REDCap) is a web application for creating and managing online surveys and databases. Clinical data management is an essential process before performing any statistical analysis to ensure the quality and reliability of study information. Processing REDCap data in R can be complex and often benefits from automation. While there are several R packages available for specific tasks, none offer an expansive approach to data management. RESULTS: The REDCapDM is an R package for accessing and managing REDCap data. It imports data from REDCap to R using either an API connection or the files in R format exported directly from REDCap. It has several functions for data processing and transformation, and it helps to generate and manage queries to clarify or resolve discrepancies found in the data. CONCLUSION: The REDCapDM package is a valuable tool for data scientists and clinical data managers who use REDCap and R. It assists in tasks such as importing, processing, and quality-checking data from their research studies.

Randomized Clinical Trial of the Need for Antibiotic Treatment for Low-Risk Catheter-Related Bloodstream Infection Caused by Coagulase-Negative Staphylococci.

According to clinical guidelines, the management of catheter-related bloodstream infections (CRBSI) due to coagulase-negative staphylococci (CoNS) includes catheter removal and antibiotic treatment for 5 to 7 days. However, in low-risk episodes, it remains uncertain whether antibiotic therapy is necessary. This randomized clinical trial aims to determine whether the non-administration of antibiotic therapy is as safe and effective as the recommended strategy in low-risk episodes of CRBSI caused by CoNS. With this purpose, a randomized, open-label, multicenter, non-inferiority clinical trial was conducted in 14 Spanish hospitals from 1 July 2019 to 31 January 2022. Patients with low-risk CRBSI caused by CoNS were randomized 1:1 after catheter withdrawal to receive/not receive parenteral antibiotics with activity against the isolated strain. The primary endpoint was the presence of any complication related to bacteremia or to antibiotic therapy within 90 days of follow-up. The secondary endpoints were persistent bacteremia, septic embolism, time until microbiological cure, and time until the disappearance of a fever. EudraCT: 2017-003612-39 INF-BACT-2017. A total of 741 patients were assessed for eligibility. Of these, 27 were included in the study; 15 (55.6%) were randomized to the intervention arm (non-antibiotic administration) and 12 (44.4%) to the control arm (antibiotic therapy as per standard practice). The primary endpoint occurred in one of the 15 patients in the intervention group (septic thrombophlebitis) and in no patients in the control group. The median time until microbiological cure was 3 days (IQR 1-3) in the intervention arm and 1.25 days (IQR 0.5-2.62) in the control arm, while the median time until fever resolution was zero days in both arms. The study was stopped due to the insufficient number of recruited patients. These results seem to indicate that low-risk CRBSI caused by CoNS can be managed without antibiotic therapy after catheter removal; efficacy and safety are not affected.

Half of the patients with subepithelial tumors present borderline or pathologic anxiety-distress and carcinophobia: a multicenter cohort study.

BACKGROUND AND AIMS: Minor nonspecific gastrointestinal subepithelial lesions (usually defined by the term 'tumor') are usually associated with a malignant illness and cancer. The aim of this study was to assess anxiety-distress and carcinophobia in patients referred to specialized monographic outpatient clinics for evaluation and treatment of this type of lesion. METHODS: Prospective, multicenter, cohort study. Specific self-reported questionnaires were used to report threatening life-experiences and to assess levels of distress (The Hospital Anxiety and Depression Scale) and cancer-related worries (The Cancer Worry Scale). RESULTS: Forty participants were included and analyzed at baseline. Pathologic and borderline anxiety were detected in 13% (5/40, 95%CI: 4-27%) and 35% (14/40, 95%CI: 21-52%) of participants, respectively, whereas, cancer-related worries (moderate to very high) were observed in 48% (19/40, 95%CI: 32-64%) of participants. Pathologic global distress was identified in 25% (10/40, 95%CI: 13-42%) of subjects. Higher educational level (university studies), a lack of lifetime psychiatric comorbidity and a lack of family history of cancer were associated with less anxiety, global distress and carcinophobia. CONCLUSIONS: Almost half of the patients diagnosed with a minor nonspecific gastrointestinal subepithelial lesion presented anxiety-distress and/or carcinophobia. Specific associations with anxiety-distress reaction and fears were detected.

Half of the patients with subepithelial tumors present borderline or pathologic anxiety-distress and carcinophobia: a multicenter cohort study

Background and Aims: Minor nonspecific gastrointestinal subepithelial lesions (usually defined by the term ‘tumor’) are usually associated with a malignant illness and cancer. The aim of this study was to assess anxiety-distress and carcinophobia in patients referred to specialized monographic outpatient clinics for evaluation and treatment of this type of lesion. Methods: Prospective, multicenter, cohort study. Specific self-reported questionnaires were used to report threatening life-experiences and to assess levels of distress (The Hospital Anxiety and Depression Scale) and cancer-related worries (The Cancer Worry Scale). Results: Forty participants were included and analyzed at baseline. Pathologic and borderline anxiety were detected in 13% (5/40, 95%CI: 4-27%) and 35% (14/40, 95%CI: 21-52%) of participants, respectively, whereas, cancer-related worries (moderate to very high) were observed in 48% (19/40, 95%CI: 32-64%) of participants. Pathologic global distress was identified in 25% (10/40, 95%CI: 13-42%) of subjects. Higher educational level (university studies), a lack of lifetime psychiatric comorbidity and a lack of family history of cancer were associated with less anxiety, global distress and carcinophobia. Conclusions: Almost half of the patients diagnosed with a minor nonspecific gastrointestinal subepithelial lesion presented anxiety-distress and/or carcinophobia. Specific associations with anxiety-distress reaction and fears were detected (AU)

Telemedicine home CPAP titration and follow-up in the COVID-19 scenario.

Introduction: Continuous positive airway pressure (CPAP) titration was dramatically affected by the coronavirus disease 2019 (COVID-19) pandemic due to increased biological risk. This study aimed to compare successful CPAP adaptation and compliance with home telemedicine CPAP titration with the usual method based on face-to-face visits. Methodology: A prospective cohort using telemedicine home CPAP titration and follow-up during the COVID-19 pandemic (TC) was compared with a retrospective cohort receiving face-to-face pre-pandemic home titration (RC). The TC included a subgroup with a smartphone application (TC-APP). Successful CPAP adaptation and compliance at 1 month of follow-up were the main endpoints, while patient satisfaction and costs were secondary endpoints. Results: 210 consecutive patients were evaluated (80 RC and 130 TC). 36 patients were in the TC-APP subgroup. CPAP titration was successful in 90% in RC versus 95% in TC and 100% in TC-APP. No compliance differences between groups were found at 1  month (4.79 h·night-1 RC, 4.33  h·night-1 TC and 4.59 h·night-1 TC-APP). Mean±sd patient satisfaction out of 10 was 7.69±2.05 in RC versus 9.02±0.64 in TC (p<0.001). 64% of the TC-APP subgroup reported that their telemedicine strategy influenced an increase in CPAP use (p=0.011). CPAP adaptation with follow-up had an estimated direct staff cost per patient of EUR 19.61±8.61 in TC with no smartphone application used versus EUR 23.79±9.94 in TC-APP (p=0.048). Conclusions: Telemedicine in CPAP titration and early follow-up is equivalent to the usual care in terms of successful adaptation and compliance, while achieving greater patient satisfaction.

Effects of the COVID-19 Pandemic on Incidence and Epidemiology of Catheter-Related Bacteremia, Spain.

We compared hospital-acquired catheter-related bacteremia (CRB) episodes diagnosed at acute care hospitals in Catalonia, Spain, during the COVID-19 pandemic in 2020 with those detected during 2007-2019. We compared the annual observed and predicted CRB rates by using the negative binomial regression model and calculated stratified annual root mean squared errors. A total of 10,030 episodes were diagnosed during 2007-2020. During 2020, the observed CRB incidence rate was 0.29/103 patient-days, whereas the predicted CRB rate was 0.14/103 patient-days. The root mean squared error was 0.153. Thus, a substantial increase in hospital-acquired CRB cases was observed during the COVID-19 pandemic in 2020 compared with the rate predicted from 2007-2019. The incidence rate was expected to increase by 1.07 (95% CI 1-1.15) for every 1,000 COVID-19-related hospital admissions. We recommend maintaining all CRB prevention efforts regardless of the coexistence of other challenges, such as the COVID-19 pandemic.

A mesoscale analysis of relations between fish species richness and environmental and anthropogenic pressures in the Mediterranean Sea.

Although there is a great knowledge about individual anthropogenic threats to different fish species in the Mediterranean Sea, little is known about how these threats accumulate and interact to affect fish species richness in conjunction with environmental dynamics. This study assesses the role of these threats in the fish richness component and identifies the main areas where the interaction between fish species richness and threats is highest. Our results show that fish richness seems to be higher in saltier and colder areas where the chlorophyll-a and phosphate concentrations are lower. Among the anthropogenic threats analyzed, the costal impact and the fishing effort seems to be the more relevant ones. Overall areas with high fish richness are mainly located along the western and northern shores, with lower values in the south-eastern regions. Areas of potential high cumulative threats are widespread in both the western and eastern basins, with fewer areas located in the south-eastern region. By describing the spatial patterns of the fish richness and which drivers explain these patterns we can also identify which anthropogenic activities can be managed more effectively to maintain and restore marine fish biodiversity in the basin.