Reopening the doors of Dutch nursing homes during the COVID-19 crisis: results of an in-depth monitoring

Objectives: On May 11, the Dutch Government allowed 26 nursing homes to welcome 1 visitor per resident, after 2 months of lockdown. The study aimed to monitor in-depth the feasibility of the regulations and their impact on the well-being of residents, their visitors, and healthcare staff. Design: Mixed-methods study in 5 of the 26 facilities; the facilities were affiliated to an academic network of nursing homes. Participants: Visitors and healthcare professionals. Intervention: Allowing visitors using local regulations based on national guidelines. Measurements: Digital questionnaire, analyzing documentation such as infection prevention control protocols, attending meetings of COVID-19 crisis teams, in-depth telephone or in-person interviews with visitors and healthcare professionals, and on-site observations. Results: National guidelines were translated with great variety into local care practice. Healthcare professionals agreed that reopening would increase the well-being of the residents and their loved ones. However, there were also great worries for increasing workload, increasing the risk of emotional exhaustion, and the risk of COVID-19 infections. Compliance with local regulations was generally satisfactory, but maintaining social distance and correctly wearing face masks appeared to be difficult. Care staff remained ambivalent for fear of infections. In general, allowing visitors was experienced as having a positive impact on the well-being of all stakeholders. Nevertheless, some residents with dementia showed negative effects. Conclusion: The complete lockdown of Dutch nursing homes had a substantial impact on the well-being of the residents. The reopening was welcomed by all stakeholders, but provided a high organizational workload as well as feelings of ambivalence among care staff. In the second wave, a more tailored approach is being implemented. However, facilities are sometimes still struggling to find the right balance between infection control and well-being

Wearable Finger Pulse Oximetry for Continuous Oxygen Saturation Measurements During Daily Home Routines of Patients With Chronic Obstructive Pulmonary Disease (COPD) Over One Week: Observational Study

BACKGROUND: Chronic obstructive pulmonary disease (COPD) patients can suffer from low blood oxygen concentrations. Peripheral blood oxygen saturation (SpO2), as assessed by pulse oximetry, is commonly measured during the day using a spot check, or continuously during one or two nights to estimate nocturnal desaturation. Sampling at this frequency may overlook natural fluctuations in SpO2. OBJECTIVE: This study used wearable finger pulse oximeters to continuously measure SpO2 during daily home routines of COPD patients and assess natural SpO2 fluctuations. METHODS: A total of 20 COPD patients wore a WristOx2 pulse oximeter for 1 week to collect continuous SpO2 measurements. A SenseWear Armband simultaneously collected actigraphy measurements to provide contextual information. SpO2 time series were preprocessed and data quality was assessed afterward. Mean SpO2, SpO2 SD, and cumulative time spent with SpO2 below 90% (CT90) were calculated for every (1) day, (2) day in rest, and (3) night to assess SpO2 fluctuations. RESULTS: A high percentage of valid SpO2 data (daytime: 93.27%; nocturnal: 99.31%) could be obtained during a 7-day monitoring period, except during moderate-to-vigorous physical activity (MVPA) (67.86%). Mean nocturnal SpO2 (89.9%, SD 3.4) was lower than mean daytime SpO2 in rest (92.1%, SD 2.9; P<.001). On average, SpO2 in rest ranged over 10.8% (SD 4.4) within one day. Highly varying CT90 values between different nights led to 50% (10/20) of the included patients changing categories between desaturator and nondesaturator over the course of 1 week. CONCLUSIONS: Continuous SpO2 measurements with wearable finger pulse oximeters identified significant SpO2 fluctuations between and within multiple days and nights of patients with COPD. Continuous SpO2 measurements during daily home routines of patients with COPD generally had high amounts of valid data, except for motion artifacts during MVPA. The identified fluctuations can have implications for telemonitoring applications that are based on daily SpO2 spot checks. CT90 values can vary greatly from night to night in patients with a nocturnal mean SpO2 around 90%, indicating that these patients cannot be consistently categorized as desaturators or nondesaturators. We recommend using wearable sensors for continuous SpO2 measurements over longer time periods to determine the clinical relevance of the identified SpO2 fluctuations.status: publishe

Reliability, construct validity and determinants of 6-minute walk test performance in patients with chronic heart failure

Background: In-depth analyses of the measurement properties of the 6-minute walk test (6MWT) in patients with chronic heart failure (CHF) are lacking. We investigated the reliability, construct validity, and determinants of the distance covered in the 6MWT (6MWD) in CHF patients.Methods: 337 patients were studied (median age 65 years, 70% male, ejection fraction 35%). Participants performed two 6MWTs on subsequent days. Demographics, anthropometrics, clinical data, ejection fraction, maximal exercise capacity, body composition, lung function, and symptoms of anxiety and depression were also assessed. Construct validity was assessed in terms of convergent, discriminant and known-groups validity. Step-wise linear regression was used.Results: 6MWT was reliable (ICC = 0.90, P &lt;0.0001). The learning effect was 31 m (95%CI 27, 35 m). Older age (&gt;= 65 years), lower lung diffusing capacity (&gt;= 80% predicted) and higher NYHA class (NYHA III) were associated with a lower likelihood of a meaningful increase in the second test (OR 0.45-0.56, P &lt;0.05 for all). The best 6MWD had moderate-to-good correlations with peak exercise capacity (r(s)= 0.54-0.69) and no-to-fair correlations with body composition, lung function, ejection fraction, and symptoms of anxiety and depression (r(s) = 0.04-0.49). Patients with higher NYHA classes had lower 6MWD. 6MWD was independently associated with maximal power output during maximal exercise, estimated glomerular filtration rate and age (51.7% of the variability).Conclusion: 6MWT was found to be reliable and valid in patients with mild-to-moderate CHF. Maximal exercise capacity, renal function and age were significant determinants of the best 6MWD. These findings strengthen the clinical utility of the 6MWT in CHF. (C) 2017 Elsevier B. V. All rights reserved.</p

Wearable Finger Pulse Oximetry for Continuous Oxygen Saturation Measurements During Daily Home Routines of Patients With Chronic Obstructive Pulmonary Disease (COPD) Over One Week:Observational Study

Background: Chronic obstructive pulmonary disease (COPD) patients can suffer from low blood oxygen concentrations. Peripheral blood oxygen saturation (SpO(2)), as assessed by pulse oximetry, is commonly measured during the day using a spot check, or continuously during one or two nights to estimate nocturnal desaturation. Sampling at this frequency may overlook natural fluctuations in SpO(2). Objective: This study used wearable finger pulse oximeters to continuously measure SpO(2) during daily home routines of COPD patients and assess natural SpO(2) fluctuations. Methods: A total of 20 COPD patients wore a WristOx(2) pulse oximeter for 1 week to collect continuous SpO(2) measurements. A SenseWear Armband simultaneously collected actigraphy measurements to provide contextual information. SpO(2) time series were preprocessed and data quality was assessed afterward. Mean SpO(2) , SpO(2) SD, and cumulative time spent with SpO(2) below 90% (CT90) were calculated for every (1) day, (2) day in rest, and (3) night to assess SpO(2) fluctuations. Results: A high percentage of valid SpO(2) data (daytime: 93.27%; nocturnal: 99.31%) could be obtained during a 7-day monitoring period, except during moderate-to-vigorous physical activity (MVPA) (67.86%). Mean nocturnal SpO(2) (89.9%, SD 3.4) was lower than mean daytime SpO(2 )in rest (92.1%, SD 2.9; P Conclusions: Continuous SpO(2) measurements with wearable finger pulse oximeters identified significant SpO(2 )fluctuations between and within multiple days and nights of patients with COPD. Continuous SpO(2 ) measurements during daily home routines of patients with COPD generally had high amounts of valid data, except for motion artifacts during MVPA. The identified fluctuations can have implications for telemonitoring applications that are based on daily SpO(2) spot checks. CT90 values can vary greatly from night to night in patients with a nocturnal mean SpO(2) around 90%, indicating that these patients cannot be consistently categorized as desaturators or nondesaturators. We recommend using wearable sensors for continuous SpO(2 )measurements over longer time periods to determine the clinical relevance of the identified SpO(2 )fluctuations

Leflunomide–hydroxychloroquine combination therapy in patients with primary Sjögren's syndrome (RepurpSS-I): a placebo-controlled, double-blinded, randomised clinical trial

Background: Primary Sjögren's syndrome is a systemic autoimmune disease characterised by secretory gland dysfunction, for which no effective therapy is available. Based on the complementary properties of leflunomide and hydroxychloroquine in inhibiting activation of key immune cells in primary Sjögren's syndrome, we aimed to evaluate the clinical efficacy and safety of leflunomide–hydroxychloroquine combination therapy in patients with primary Sjögren's syndrome. Methods: We did a placebo-controlled, double-blinded, phase 2A randomised clinical trial in patients with primary Sjögren's syndrome at the University Medical Center Utrecht (Utrecht, Netherlands). Eligible patients were aged 18–75 years, had a European League Against Rheumatism (EULAR) Sjögren's syndrome disease activity index (ESSDAI) score of 5 or higher, and a lymphocytic focus score of 1 or higher in labial salivary gland biopsy specimens. Patients were randomly assigned (2:1) with block randomisation (block size of six) to receive leflunomide 20 mg and hydroxychloroquine 400 mg daily or placebo for 24 weeks. The primary endpoint was the between-group difference in change in ESSDAI scores from 0 to 24 weeks, adjusted for baseline ESSDAI score. Patients were analysed according to the intention-to-treat principle. This study is registered with EudraCT, 2014–003140–12. Findings: Between March 7, 2016, and Nov 30, 2017, 37 patients were screened, of whom 29 patients (28 women and one man) were enrolled. 21 patients were assigned to receive leflunomide–hydroxychloroquine and eight patients were assigned to receive placebo. One patient in the placebo group required high-dose prednisone to treat polymyalgia rheumatica at week 13 and was excluded from the primary analysis. From 0 to 24 weeks, the mean difference in ESSDAI score, adjusted for baseline values, in the leflunomide–hydroxychloroquine group compared with the placebo group was −4·35 points (95% CI −7·45 to −1·25, p=0·0078). No serious adverse events occurred in the leflunomide–hydroxychloroquine group and two serious adverse events occurred in the placebo group (hospital admission for pancreatitis and hospital admission for nephrolithiasis). The most common adverse events in the leflunomide–hydroxychloroquine group were gastrointestinal discomfort (11 patients [52%] vs two [25%] in the placebo group), modest transient increases in alanine aminotransferase (ten [48%] vs one [13%]), and short episodes of general malaise and shivering (nine [43%] vs one [13%]). Interpretation: Leflunomide–hydroxychloroquine was safe and resulted in a clinical response in patients with primary Sjögren's syndrome. These results warrant further evaluation of leflunomide–hydroxychloroquine combination therapy in larger clinical trials. Funding: ZonMw