To assess the completeness of recording of relevant signs, symptoms, and measurements in Dutch free text fields of primary care electronic health records (EHR) of adults with lower respiratory tract ...infections (LRTI).
Retrospective cohort study embedded in a prediction modeling project using routine health care data of the Julius General Practitioners’ Network of adult patients with LRTI. Free text fields of 1,000 primary care consultations of LRTI episodes between 2016 and 2019 were manually annotated to retrieve data on the recording of sixteen relevant signs, symptoms, and measurements.
For 12/16 (75%) of the relevant signs, symptoms, and measurements, more than 50% of the values was not recorded. The patterns of recorded values indicated selective recording of positive or abnormal values. Recording rates varied across consultation type (physical consultation vs. home visit), diagnosis (acute bronchitis vs. pneumonia), antibiotic prescription issued (yes vs. no), and between practices.
In EHR of primary care LRTI patients, recording of signs, symptoms, and measurements in free text fields is incomplete and possibly selective. When using free text data in EHR-based research, careful consideration of its recording patterns and appropriate missing data handling techniques is therefore required.
Background
A previous individual participant data (IPD) meta‐analysis showed that the Wells rule and D‐dimer testing cannot exclude suspected deep vein thrombosis (DVT) in cancer patients.
Objectives
...To explore reasons for this reduced diagnostic accuracy and to optimize the diagnostic pathway for cancer patients suspected of DVT.
Patients and Methods
Using IPD from 13 studies in patients with suspected DVT, DVT prevalence and the predictive value of the Wells rule items and D‐dimer testing were compared between patients with and without cancer. Next, we developed a prediction model with five variables selected from all available diagnostic predictors.
Results
Among the 10 002 suspected DVT patients, there were 834 patients with cancer. The median prevalence of DVT in these patients with cancer was 37.5% (interquartile range IQR, 30.8‐45.5), whereas it was 15.1% (IQR, 11.5‐16.7) in patients without cancer. Diagnostic performance of individual Wells rule items and D‐dimer testing was similar across patients with and without cancer, except “immobility” and “history of DVT.” The newly developed rule showed a pooled c‐statistic 0.80 (95% confidence interval CI, 0.75‐0.83) and good calibration. However, using this model, still only 4.3% (95% CI, 3.0‐5.7) of the suspected patients with cancer could be identified with a predicted DVT posttest probability of <2%.
Conclusions
Likely because of the high prevalence of DVT, clinical models followed by D‐dimer testing fail to rule out DVT efficiently in cancer patients suspected of DVT. Direct referral for compression ultrasonography appears to be the preferred approach for diagnosis of suspected DVT in cancer patients.
Integrated care is effective in reducing all-cause mortality in patients with atrial fibrillation (AF) in primary care, though time and resource intensive. The aim of the current study was to assess ...whether integrated care should be directed at all AF patients equally. The ALL-IN trial (n = 1,240 patients, median age 77 years) was a cluster-randomized trial in which primary care practices were randomized to provide integrated care or usual care to AF patients aged 65 years and older. Integrated care comprised of (i) anticoagulation monitoring, (ii) quarterly checkups and (iii) easy-access consultation with cardiologists. For the current analysis, cox proportional hazard analysis with all clinical variables from the CHA.sub.2 DS.sub.2 -VASc score was used to predict all-cause mortality in the ALL-IN trial. Subsequently, the hazard ratio and absolute risk reduction were plotted as a function of this predicted mortality risk to explore treatment heterogeneity. Under usual care, after a median of 2 years follow-up the absolute risk of all-cause mortality in the highest-risk quarter was 31.0%, compared to 4.6% in the lowest-risk quarter. On the relative scale, there was no evidence of treatment heterogeneity (p for interaction = 0.90). However, there was substantial treatment heterogeneity on the absolute scale: risk reduction in the lowest risk- quarter of risk 3.3% (95% CI -0.4% - 7.0) compared to 12.0% (95% CI 2.7% - 22.0) in the highest risk quarter. While the relative degree of benefit from integrated AF care is similar in all patients, patients with a high all-cause mortality risk have a greater benefit on an absolute scale and should therefore be prioritized when implementing integrated care.
There is ambiguity whether frail patients with atrial fibrillation managed with vitamin K antagonists (VKAs) should be switched to a non-vitamin K oral anticoagulant (NOAC).
We conducted a pragmatic, ...multicenter, open-label, randomized controlled superiority trial. Older patients with atrial fibrillation living with frailty (≥75 years of age plus a Groningen Frailty Indicator score ≥3) were randomly assigned to switch from international normalized ratio-guided VKA treatment to an NOAC or to continued VKA treatment. Patients with a glomerular filtration rate <30 mL·min
·1.73 m
or with valvular atrial fibrillation were excluded. Follow-up was 12 months. The cause-specific hazard ratio was calculated for occurrence of the primary outcome that was a major or clinically relevant nonmajor bleeding complication, whichever came first, accounting for death as a competing risk. Analyses followed the intention-to-treat principle. Secondary outcomes included thromboembolic events.
Between January 2018 and June 2022, a total of 2621 patients were screened for eligibility and 1330 patients were randomly assigned (mean age 83 years, median Groningen Frailty Indicator score 4). After randomization, 6 patients in the switch-to-NOAC arm and 1 patient in the continue-with-VKA arm were excluded due to the presence of exclusion criteria, leaving 662 patients switched from a VKA to an NOAC and 661 patients continued VKAs in the intention-to-treat population. After 163 primary outcome events (101 in the switch arm, 62 in the continue arm), the trial was stopped for futility according to a prespecified futility analysis. The hazard ratio for our primary outcome was 1.69 (95% CI, 1.23-2.32). The hazard ratio for thromboembolic events was 1.26 (95% CI, 0.60-2.61).
Switching international normalized ratio-guided VKA treatment to an NOAC in frail older patients with atrial fibrillation was associated with more bleeding complications compared with continuing VKA treatment, without an associated reduction in thromboembolic complications.
URL: https://eudract.ema.europa.eu; Unique identifier: 2017-000393-11. URL: https://eudract.ema.europa.eu; Unique identifier: 6721 (FRAIL-AF study).
Aim
To investigate the effects of off‐label non‐vitamin K oral anticoagulant (NOAC) dose reduction compared with on‐label standard dosing in atrial fibrillation (AF) patients in routine care.
Methods
...Population‐based cohort study using data from the United Kingdom Clinical Practice Research Datalink, comparing adults with non‐valvular AF receiving an off‐label reduced NOAC dose to patients receiving an on‐label standard dose. Outcomes were ischaemic stroke, major/non‐major bleeding and mortality. Inverse probability of treatment weighting and inverse probability of censoring weighting on the propensity score were applied to adjust for confounding and informative censoring.
Results
Off‐label dose reduction occurred in 2466 patients (8.0%), compared with 18 108 (58.5%) on‐label standard‐dose users. Median age was 80 years (interquartile range IQR 73.0‐86.0) versus 72 years (IQR 66‐78), respectively. Incidence rates were higher in the off‐label dose reduction group compared to the on‐label standard dose group, for ischaemic stroke (0.94 vs 0.70 per 100 person years), major bleeding (1.48 vs 0.83), non‐major bleeding (6.78 vs 6.16) and mortality (10.12 vs 3.72). Adjusted analyses resulted in a hazard ratio of 0.95 (95% confidence interval CI 0.57‐1.60) for ischaemic stroke, 0.88 (95% CI 0.57‐1.35) for major bleeding, 0.81 (95% CI 0.67‐0.98) for non‐major bleeding and 1.34 (95% CI 1.12‐1.61) for mortality.
Conclusion
In this large population‐based study, the hazards for ischaemic stroke and major bleeding were low, and similar in AF patients receiving an off‐label reduced NOAC dose compared with on‐label standard dose users, while non‐major bleeding risk appeared to be lower and mortality risk higher. Caution towards prescribing an off‐label reduced NOAC dose is therefore required.
Cardiovascular conditions were shown to be predictive of clinical deterioration in hospitalised patients with coronavirus disease 2019 (COVID-19). Whether this also holds for outpatients managed in ...primary care is yet unknown. The aim of this study was to determine the incremental value of cardiovascular vulnerability in predicting the risk of hospital referral in primary care COVID-19 outpatients.
Analysis of anonymised routine care data extracted from electronic medical records from three large Dutch primary care registries.
Primary care.
Consecutive adult patients seen in primary care for COVID-19 symptoms in the 'first wave' of COVID-19 infections (March 1 2020 to June 1 2020) and in the 'second wave' (June 1 2020 to April 15 2021) in the Netherlands.
A multivariable logistic regression model was fitted to predict hospital referral within 90 days after first COVID-19 consultation in primary care. Data from the 'first wave' was used for derivation (n = 5,475 patients). Age, sex, the interaction between age and sex, and the number of cardiovascular conditions and/or diabetes (0, 1, or ≥2) were pre-specified as candidate predictors. This full model was (i) compared to a simple model including only age and sex and its interaction, and (ii) externally validated in COVID-19 patients during the 'second wave' (n = 16,693).
The full model performed better than the simple model (likelihood ratio test p<0.001). Older male patients with multiple cardiovascular conditions and/or diabetes had the highest predicted risk of hospital referral, reaching risks above 15-20%, whereas on average this risk was 5.1%. The temporally validated c-statistic was 0.747 (95%CI 0.729-0.764) and the model showed good calibration upon validation.
For patients with COVID-19 symptoms managed in primary care, the risk of hospital referral was on average 5.1%. Older, male and cardiovascular vulnerable COVID-19 patients are more at risk for hospital referral.
The long-term risk for major bleeding in patients receiving extended (beyond the initial 3 to 6 months) anticoagulant therapy for a first unprovoked venous thromboembolism (VTE) is uncertain.
To ...determine the incidence of major bleeding during extended anticoagulation of up to 5 years among patients with a first unprovoked VTE, overall, and in clinically important subgroups.
MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials from inception to 23 July 2021.
Randomized controlled trials (RCTs) and prospective cohort studies reporting major bleeding among patients with a first unprovoked VTE who were to receive oral anticoagulation for a minimum of 6 additional months after completing at least 3 months of initial anticoagulant treatment.
Two reviewers independently abstracted data and assessed study quality. Unpublished data required for analyses were obtained from authors of included studies.
Among the 14 RCTs and 13 cohort studies included in the analysis, 9982 patients received a vitamin K antagonist (VKA) and 7220 received a direct oral anticoagulant (DOAC). The incidence of major bleeding per 100 person-years was 1.74 events (95% CI, 1.34 to 2.20 events) with VKAs and 1.12 events (CI, 0.72 to 1.62 events) with DOACs. The 5-year cumulative incidence of major bleeding with VKAs was 6.3% (CI, 3.6% to 10.0%). Among patients receiving either a VKA or a DOAC, the incidence of major bleeding was statistically significantly higher among those who were older than 65 years or had creatinine clearance less than 50 mL/min, a history of bleeding, concomitant use of antiplatelet therapy, or a hemoglobin level less than 100 g/L. The case-fatality rate of major bleeding was 8.3% (CI, 5.1% to 12.2%) with VKAs and 9.7% (CI, 3.2% to 19.2%) with DOACs.
Data were insufficient to estimate incidence of major bleeding beyond 1 year of extended anticoagulation with DOACs.
In patients with a first unprovoked VTE, the long-term risks and consequences of anticoagulant-related major bleeding are considerable. This information will help inform patient prognosis and guide decision making about treatment duration for unprovoked VTE.
Canadian Institutes of Health Research. (PROSPERO: CRD42019128597).
ObjectivesRecent studies in referred populations of patients with superficial venous thrombosis (SVT) report risks of venous thromboembolic (VTE) sequelae (deep vein thrombosis or pulmonary embolism) ...as high as 25%. Likely, these estimates are lower in non-referred patients, but large-scale population-based studies are lacking. We aimed to estimate the incidence rate of SVT in primary care and quantify its risk of VTE sequelae.DesignA retrospective cohort study, using International Classification of Primary Care coding (K94.02) combined with free text searching (synonyms for SVT) to capture all SVT events. All patients were followed up for 3 months using manual free text searching.SettingPrimary care.ParticipantsAll patients enlisted with general practitioners within the Utrecht General Practitioner Network between 2010 and 2016 (1 534 845 person-years follow-up).Main outcome measuresThe incidence rate of SVT was expressed as the number of SVT events per 1000 person-years of follow-up and the 3-month cumulative incidence of VTE events was calculated. Logistic regression analysis was used to compare patients with SVT with and without VTE sequelae.ResultsA total of 2008 SVT cases were identified, that is, an SVT incidence rate of 1.31 (95% CI 1.25 to 1.37) per 1000 person-years follow-up, with higher rates notably with increasing age. VTE sequelae occurred in 83 patients; 51 at the time of SVT diagnosis and 32 patients during follow-up (total cumulative incidence of 4.1%; 95% CI 3.3% to 5.1%), and were more frequent in those with an active malignancy (OR 2.19; 95% 0.97 to 4.95) and less frequent in those with varicose veins at baseline (OR 0.57, 95% CI 0.34 to 0.94).ConclusionWe found an incidence rate of SVT in primary care of 1.31 per 1000 person-years. The risks of VTE sequelae was relatively low at 4.1%, with the highest risk in patients with cancer and in those who experience an SVT in the absence of varicose veins.
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