Patients' and GPs' views and expectations of home monitoring with a pulse oximeter: a mixed-methods process evaluation of a pilot randomised controlled trial

BACKGROUND: Research on how home monitoring with a pulse oximeter is executed and experienced by patients with an acute illness such as COVID-19 and their GPs is scarce. AIM: To examine the process of structured home monitoring with a pulse oximeter for patients with COVID-19, their caregivers, and their GPs. DESIGN AND SETTING: This was a mixed-method process evaluation alongside a pilot feasibility randomised controlled trial. Patients drawn from a general practice setting, with COVID-19, and aged ≥40 years with cardiovascular comorbidities were included. METHOD: Quantitative trial data from 21 intervention group participants (age 63.2 years) were used, plus qualitative data from semi-structured interviews with 15 patients (age 62.9 years), eight informal caregivers, and 10 GPs. RESULTS: Adherence to the intervention was very high; 97.6% of protocolised peripheral oxygen saturation (SpO2) measurements in the first 14 days until admission to hospital were recorded (677/694, median daily per patient 2.7). Three identified themes from the interviews were: (a) user-friendliness of home monitoring: easy use of the pulse oximeter and patient preference of a three times daily measurement scheme; (b) patient empowerment: pulse oximeter use enhanced patient self-assurance and empowered patients and informal caregivers in disease management; and (c) added value to current clinical decision making. GPs perceived the pulse oximeter as a useful diagnostic tool and did not experience any additional workload. They felt more secure with remote monitoring with a pulse oximeter than only phone-based monitoring, but emphasised the need to keep an overall view on the patient's condition. CONCLUSION: Structured home monitoring by pulse oximetry supports patients and their informal caregivers in managing, and GPs in monitoring, acute COVID-19 disease. It appears suitable for use in acutely ill patients in general practice

Real-life impact of clinical prediction rules for venous thromboembolism in primary care: a cross-sectional cohort study

OBJECTIVE: Clinical prediction rules (CPRs) followed by D-dimer testing were shown to safely rule out venous thromboembolism (VTE) in about half of all suspected patients in controlled and experienced study settings. Yet, its real-life impact in primary care is unknown. The aim of this study was to determine the real-life impact of CPRs for suspected VTE in primary care. DESIGN: Cross-sectional cohort study. SETTING: Primary care in the Netherlands. PARTICIPANTS: Patients with suspected deep venous thrombosis (n=993) and suspected pulmonary embolism (n=484). INTERVENTIONS: General practitioners received an educational instruction on how to use CPRs in suspected VTE. We did not rectify incorrect application of the CPR in order to mimic daily clinical care. MAIN OUTCOME MEASURES: Primary outcomes were the diagnostic failure rate, defined as the 3-month incidence of VTE in the non-referred group, and the efficiency, defined as the proportion of non-referred patients in the total study population. Secondary outcomes were determinants for and consequences of incorrect application of the CPRs. RESULTS: In 267 of the included 1477 patients, VTE was confirmed. When CPRs were correctly applied, the failure rate was 1.51% (95% CI 0.77 to 2.86), and the efficiency was 58.1% (95% CI 55.2 to 61.0). However, the CPRs were incorrectly applied in 339 patients, which resulted in an increased failure rate of 3.31% (95% CI 1.07 to 8.76) and a decreased efficiency of 35.7% (95% CI 30.6 to 41.1). The presence of concurrent heart failure increased the likelihood of incorrect application (adjusted OR 3.26; 95% CI 1.47 to 7.21). CONCLUSIONS: Correct application of CPRs for VTE in primary care is associated with an acceptable low failure rate at a high efficiency. Importantly, in nearly a quarter of patients, the CPRs were incorrectly applied that resulted in a higher failure rate and a considerably lower efficiency

Predictive factors of clot propagation in patients with superficial venous thrombosis towards deep venous thrombosis and pulmonary embolism: a systematic review and meta-analysis

Objective A subset of patients with superficial venous thrombosis (SVT) experiences clot propagation towards deep venous thrombosis (DVT) and/or pulmonary embolism (PE). The aim of this systematic review is to identify all clinically relevant cross-sectional and prognostic factors for predicting thrombotic complications in patients with SVT. Design Systematic review. Data sources PubMed/MEDLINE and Embase were systematically searched until 3 March 2023. Eligibility criteria Original research studies with patients with SVT, DVT and/or PE as the outcome and presenting cross-sectional or prognostic predictive factors. Data extraction and synthesis of results The CHecklist for critical Appraisal and data extraction for systematic Reviews of prediction Modelling (CHARMS) checklist for prognostic factor studies was used for systematic extraction of study characteristics. Per identified predictive factor, relevant estimates of univariable and multivariable predictor—outcome associations were extracted, such as ORs and HRs. Estimates of association for the most frequently reported predictors were summarised in forest plots, and meta-analyses with heterogeneity were presented. The Quality in Prognosis Studies (QUIPS) tool was used for risk of bias assessment and Grading of Recommendations, Assessment, Development and Evaluations (GRADE) for assessing the certainty of evidence. Results Twenty-two studies were included (n=10 111 patients). The most reported predictive factors were high age, male sex, history of venous thromboembolism (VTE), absence of varicose veins and cancer. Pooled effect estimates were heterogenous and ranged from OR 3.12 (95% CI 1.75 to 5.59) for the cross-sectional predictor cancer to OR 0.92 (95% CI 0.56 to 1.53) for the prognostic predictor high age. The level of evidence was rated very low to low. Most studies were scored high or moderate risk of bias. Conclusions Although the pooled estimates of the predictors high age, male sex, history of VTE, cancer and absence of varicose veins showed predictive potential in isolation, variability in study designs, lack of multivariable adjustment and high risk of bias prevent firm conclusions. High-quality, multivariable studies are necessary to be able to identify individual SVT risk profiles

Managing the Increasing Burden of Atrial Fibrillation through Integrated Care in Primary Care: A Cost-Effectiveness Analysis

INTRODUCTION: Integrated care for patients with atrial fibrillation (AF) in primary care reduced mortality compared to usual care. We assessed the cost-effectiveness of this approach. METHODS: Dutch primary care practices were randomised to provide integrated care for AF patients or usual care. A cost-effectiveness analysis was performed from a societal perspective with a 2-year time horizon to estimate incremental costs and Quality Adjusted Life Years (QALYs). A sensitivity analysis was performed, imputing missing questionnaires for a large group of usual care patients. RESULTS: 522 patients from 15 intervention practices were compared to 425 patients from 11 usual care practices. No effect on QALYs was seen, while mean costs indicated a cost reduction between €865 (95% percentile interval (PI) -€5730 to €3641) and €1343 (95% PI -€6534 to €3109) per patient per 2 years. The cost-effectiveness probability ranged between 36% and 54%. In the sensitivity analysis, this increased to 95%-99%. DISCUSSION: Results should be interpreted with caution due to missing information for a large proportion of usual care patients. CONCLUSION: The higher costs from extra primary care consultations were likely outweighed by cost reductions for other resources, yet this study doesn't give sufficient clarity on the cost-effectiveness of integrated AF care

Sex- and age specific association of new-onset atrial fibrillation with in-hospital mortality in hospitalised COVID-19 patients

BACKGROUND: Coronavirus disease 2019 (COVID-19) is a systemic disease with cardiovascular involvement, including cardiac arrhythmias. Notably, new-onset atrial fibrillation (AF) and atrial flutter (AFL) during hospitalisation in COVID-19 patients has been associated with increased mortality. However, how this risk is impacted by age and sex is still poorly understood. METHODS: For this multicentre cohort study, we extracted demographics, medical history, occurrence of electrical disorders and in-hospital mortality from the large international patient registry CAPACITY-COVID. For each electrical disorder, prevalence during hospitalisation was calculated. Subsequently, we analysed the incremental prognostic effect of developing AF/AFL on in-hospital mortality, using multivariable logistic regression analyses, stratified for sex and age. RESULTS: In total, 5782 patients (64% male; median age 67) were included. Of all patients 11.0% (95% CI 10.2–11.8) experienced AF and 1.6% (95% CI 1.3–1.9) experienced AFL during hospitalisation. Ventricular arrhythmias were rare (<0.8% (95% CI 0.6–1.0)) and a conduction disorder was observed in 6.3% (95% CI 5.7–7.0). An event of AF/AFL appeared to occur more often in patients with pre-existing heart failure. After multivariable adjustment for age and sex, new-onset AF/AFL was significantly associated with a poorer prognosis, exemplified by a two- to three-fold increased risk of in-hospital mortality in males aged 60–72 years, whereas this effect was largely attenuated in older male patients and not observed in female patients. CONCLUSION: In this large COVID-19 cohort, new-onset AF/AFL was associated with increased in-hospital mortality, yet this increased risk was restricted to males aged 60–72 years

Validation of two age dependent D-dimer cut-off values for exclusion of deep vein thrombosis in suspected elderly patients in primary care: retrospective, cross sectional, diagnostic analysis

Objective To determine whether the use of age adapted D-dimer cut-off values can be translated to primary care patients who are suspected of deep vein thrombosis

Home monitoring by pulse oximetry of primary care patients with COVID-19: a pilot randomised controlled trial

Background Pulse oximetry as a home or remote monitoring tool accelerated during the pandemic for patients with COVID-19, but evidence on its use is lacking. Aim To assess the feasibility of home monitoring by pulse oximetry of patients aged ?40 years with cardiovascular comorbidity and moderate-To-severe COVID-19. Design and setting A primary care-based, open, pilot randomised controlled trial, with nested process evaluation, was undertaken in the Netherlands. Method From November 2020 to June 2021, eligible patients presenting to one of 14 participating Dutch general practices were randomly allocated to regular measurement of peripheral oxygen saturation (at least three SpO2 measurements per day for 14 days) with a validated pulse oximeter or usual care. Results All 41 participants (21 intervention, 20 usual care) completed the 45-day follow-up period. Overall, the intervention group performed 97.6% of protocolised measurements; the median daily measurement per participant was 2.7 (interquartile range 1 4). Hypoxemia (SpO2 94%) was reported in 10 participants (in 52 measurements); of those, six consulted the GP as instructed. Participants reported a high feeling of safety (0 100 visual analogue scale): 71.8 for the intervention group versus 59.8 for the control (P = 0.09). Primary care consultations were similar across groups: 50 for the intervention versus 51 for the control. Eleven visits by 10 participants were made to the emergency department (eight from the intervention group versus three from usual care), of which six participants were hospitalised (five intervention versus one usual care). No participants were admitted to the intensive care unit or died during follow-up. Conclusion Home monitoring of patients with moderate-Tosevere COVID-19 by pulse oximetry appeared feasible; adherence was high, patients reported a high feeling of safety, while the number of primary care consultations remained similar to usual care

Estimated causal effects of common respiratory infections on cardiovascular risk: a meta-analysis

OBJECTIVE: Literature supports associations between common respiratory tract infections (RTIs) and risk of cardiovascular diseases, yet the importance of RTIs for cardiovascular risk management remains less understood. This systematic review and meta-analysis aimed to estimate the causal effects of RTIs on occurrence of cardiovascular diseases in the general population. METHODS: MEDLINE and EMBASE were systematically searched up to 4 November 2022. Eligible were all aetiological studies evaluating risk of cardiovascular outcomes after exposure to common RTIs within any follow-up duration. Evidence was pooled using random-effects models if data allowed. The ROBINS-E and GRADE approaches were used to rate risk of bias and certainty of evidence, respectively. All assessments were performed in duplicate. RESULTS: We included 34 studies (65 678 650 individuals). Most studies had a high risk of bias. COVID-19 likely increases relative risk (RR (95% CI)) of myocardial infarction (3.3 (1.0 to 11.0)), stroke (3.5 (1.2 to 10)), pulmonary embolism (24.6 (13.5 to 44.9)) and deep venous thrombosis (7.8 (4.3 to 14.4)) within 30 days after infection (GRADE: moderate) and about twofold within 1 year (GRADE: low to moderate). Other RTIs also likely increase the RR of myocardial infarction (2.9 (95% CI 1.8 to 4.9)) and stroke (2.6 (95% CI 1.1 to 6.4)) within 30 days (GRADE: moderate), and to a lesser extent with longer follow-up. CONCLUSIONS: RTIs likely increase the risk of cardiovascular diseases about 1.5-5 fold within 1 month after infection. RTIs may, therefore, have clinical relevance as target for cardiovascular risk management, especially in high-risk populations. PROSPERO REGISTRATION NUMBER: CRD42023416277

Incidence and individual risk prediction of post-COVID-19 cardiovascular disease in the general population: a multivariable prediction model development and validation study

Aims Previous studies suggest relatively increased cardiovascular risk after COVID-19 infection. This study assessed incidence and explored individual risk and timing of cardiovascular disease occurring post-COVID-19 in a large primary care database. Methods Data were extracted from the UK’s Clinical Practice Research Datalink. Incidence rates within 180 days post-infection were esti- and results mated for arterial or venous events, inflammatory heart disease, and new-onset atrial fibrillation or heart failure. Next, multivariable logistic regression models were developed on 220 751 adults with COVID-19 infection before 1 December 2020 using age, sex and traditional cardiovascular risk factors. All models were externally validated in (i) 138 034 vaccinated and (ii) 503 404 unvaccinated adults with a first COVID-19 infection after 1 December 2020. Discriminative performance and calibration were evaluated with internal and external validation. Increased incidence rates were observed up to 60 days after COVID-19 infection for venous and arterial cardiovascular events and new-onset atrial fibrillation, but not for inflammatory heart disease or heart failure, with the highest rate for venous events (13 per 1000 person-years). The best prediction models had c-statistics of 0.90 or higher. However, <5% of adults had a predicted 180-day outcome-specific risk larger than 1%. These rare outcomes complicated calibration. Conclusion Risks of arterial and venous cardiovascular events and new-onset atrial fibrillation are increased within the first 60 days after COVID-19 infection in the general population. Models’ c-statistics suggest high discrimination, but because of the very low absolute risks, they are insufficient to inform individual risk management