Oral anticoagulant treatment after bioprosthetic valvular intervention or valvuloplasty in patients with atrial fibrillation—A SWEDEHEART study

Aims To describe the prevalence of atrial fibrillation (AF), use of oral anticoagulants (OAC) and change in antithrombotic treatment patterns during follow-up after valve intervention with a biological prosthesis or valvuloplasty. Methods and results All patients with history of AF or new-onset AF discharged alive after valvular intervention (biological prosthesis or valvuloplasty) between 2010–2016 in Sweden were included (n = 7,362). Information about comorbidities was collected from national patient registers. Exposure to OAC was based on pharmacy dispensation data. In total 4,800 (65.2%) patients had a history of AF, and 2,562 (34.8%) patients developed new-onset AF, with 999 (39.0%) developing new-onset AF within 3 months after intervention. The proportion of patients with biological valve prosthesis was higher in patients with new-onset AF compared to history of AF (p<0.001). CHA2DS2-VASc score ≥2 was observed in 83.1% and 75.5% patients with history of AF and new-onset AF, respectively. Warfarin was more frequently dispensed than NOAC at discharge in patients with history of AF (43.9% vs 7.3%), and in patients with new-onset AF (36.6% vs 17.1%). Almost half of the AF population was not dispensed on any OAC at discharge (48.8% in patients with history of AF and 46.3% in patients with new-onset AF). Conclusion In this real world study of patients with AF and recent valvular intervention, risk of new-onset AF after valvular intervention is high emphasizing need for frequent rhythm monitoring after intervention. A considerable undertreatment with OAC was observed despite being indicated for the majority of the patients. Warfarin was the OAC most frequently dispensed.

The PID Life Index: an interactive tool to measure the status of the PID healthcare environment in any given country

Background The “Primary Immunodeficiencies (PIDs) principles of care” were published in 2014 as the gold standard for care of patients with PIDs, setting a common goal for stakeholders to ensure that patients with PID have access to appropriate care and good quality of life. Since then, IPOPI (the International Patient Organisation for Primary Immunodeficiencies), has been working with national PID patient organisations as well as collaborating with scientific and medical institutions and experts to bring these principles closer to the day-to-day life of individuals with PIDs. Method The six PID Principles of Care were revised to consider advances in the field, as well as political developments that had occurred after their initial publication in 2014. Based on this revision the list was updated, and a new principle was added. The six established principles were: diagnosis, treatment, universal health coverage, specialised centres, national patient organisations and registries. Each principle was structured and measured through a series of criteria, and was given the same weight, as they have been considered to all be equally important. Specific weights were attributed to the criteria depending on their relevance and importance to quantify the principle. The index was translated into a survey for data collection: initially involving data from selected countries for a pilot, followed by integration of data from IPOPI’s national member organisations and key countries. Results The PID Life Index was developed in 2020 to assess the status of the PID environment and the implementation of the 6 principles worldwide. The Index allows for benchmarking countries either according to a set of principles and criteria or based on the user’s preferences. This can be displayed in an interactive map or through a data visualisation system. Conclusion The PID Life Index has been developed successfully and has potential to become an important source of information for PID stakeholders, to increase awareness and information as well as support advocacy initiatives on PIDs nationally, regionally or globally.

Generalizable EHR-R-REDCap pipeline for a national multi-institutional rare tumor patient registry

Objective To develop a clinical informatics pipeline designed to capture large-scale structured Electronic Health Record (EHR) data for a national patient registry. Materials and Methods The EHR-R-REDCap pipeline is implemented using R statistical software to remap and import structured EHR data into the Research Electronic Data Capture (REDCap)-based multi-institutional Merkel Cell Carcinoma (MCC) Patient Registry using an adaptable data dictionary. Results Clinical laboratory data were extracted from EPIC Clarity across several participating institutions. Laboratory values (Labs) were transformed, remapped, and imported into the MCC registry using the EHR labs abstraction (eLAB) pipeline. Forty-nine clinical tests encompassing 482 450 results were imported into the registry for 1109 enrolled MCC patients. Data-quality assessment revealed highly accurate, valid labs. Univariate modeling was performed for labs at baseline on overall survival (N = 176) using this clinical informatics pipeline. Conclusion We demonstrate feasibility of the facile eLAB workflow. EHR data are successfully transformed and bulk-loaded/imported into a REDCap-based national registry to execute real-world data analysis and interoperability.

The effect of parathyroidectomy compared to non-surgical surveillance on kidney function in primary hyperparathyroidism: a nationwide historic cohort study

Background Patients with primary hyperparathyroidism (pHPT) and impaired kidney function (estimated glomerular filtration rate (eGFR) < 60 mL/min) are offered parathyroidectomy (PTX) to protect them from further complications. Surprisingly, two recent uncontrolled cohort studies have suggested a further decrease in kidney function following PTX. We aimed to examine the effects of PTX compared to non-surgical surveillance on kidney function in pHPT patients. Methods Historic cohort study. From the Danish National Patient Registry (NPR) and major medical biochemistry laboratories in Denmark, we identified 3585 patients with biochemically confirmed pHPT among whom n = 1977 (55%) were treated with PTX (PTX-group) whereas n = 1608 (45%) were followed without surgery (non-PTX group). Baseline was defined as time of diagnosis and kidney function was re-assessed 9–15 months after PTX (PTX group) or 9–15 months after diagnosis (non-PTX group). Results At follow-up, eGFR had decreased significantly in the PTX- compared to the non-PTX-group (median − 4% vs. − 1%, p < 0.01). Stratification by baseline eGFR showed that the decrease was significant for those with a baseline eGFR value of 80–89 and > 90 mL/min, but not for those with lower eGFR values. Findings did not differ between patients with mild compared to moderate/severe hypercalcemia. However, after mutual adjustments, we identified baseline levels of calcium, PTH, and eGFR as well as age and treatment (PTX vs. no-PTX) as independent predictors for changes in kidney function. Conclusion Compared to non-surgical surveillance, PTX is associated with a small but significant decrease in kidney function in pHPT patients with an initial normal kidney function.

Total, hemi, or dual-mobility arthroplasty for the treatment of femoral neck fractures in patients with neurological disease

Aims The aim of this study was to investigate the potentially increased risk of dislocation in patients with neurological disease who sustain a femoral neck fracture, as it is unclear whether they should undergo total hip arthroplasty (THA) or hemiarthroplasty (HA). A secondary aim was to investgate whether dual-mobility components confer a reduced risk of dislocation in these patients. Methods We undertook a longitudinal cohort study linking the Swedish Hip Arthroplasty Register with the National Patient Register, including patients with a neurological disease presenting with a femoral neck fracture and treated with HA, a conventional THA (cTHA) with femoral head size of ≤ 32 mm, or a dual-mobility component THA (DMC-THA) between 2005 and 2014. The dislocation rate at one- and three-year revision, reoperation, and mortality rates were recorded. Cox multivariate regression models were fitted to calculate adjusted hazard ratios (HRs). Results A total of 9,638 patients with a neurological disease who also underwent unilateral arthroplasty for a femoral neck fracture were included in the study. The one-year dislocation rate was 3.7% after HA, 8.8% after cTHA < 32 mm), 5.9% after cTHA (= 32 mm), and 2.7% after DMC-THA. A higher risk of dislocation was associated with cTHA (< 32 mm) compared with HA (HR 1.90 (95% confidence interval (CI) 1.26 to 2.86); p = 0.002). There was no difference in the risk of dislocation with DMC-THA (HR 0.68 (95% CI 0.26 to 1.84); p = 0.451) or cTHA (= 32 mm) (HR 1.54 (95% CI 0.94 to 2.51); p = 0.083). There were no differences in the rate of reoperation and revision-free survival between the different types of prosthesis and sizes of femoral head. Conclusion Patients with a neurological disease who sustain a femoral neck fracture have similar rates of dislocation after undergoing HA or DMC-THA. Most patients with a neurological disease are not eligible for THA and should thus undergo HA, whereas those eligible for THA could benefit from a DMC-THA. Cite this article: Bone Joint J 2022;104-B(1):134–141.

The Indian healthcare system turns to digital health: eSanjeevaniOPD as a national telemedicine service

Healthcare infrastructure in the emerging economies is largely concentrated in their urban areas, and the burgeoning rural population is usually deprived of quality medical care. Telemedicine systems are expected to bridge this gap. This case study documents telemedicine’s significance and allows students to examine India’s national patient-to-doctor telemedicine service, eSanjeevaniOPD. The portal provides free and contactless consultation by a government doctor using video calls. COVID-19 hastened the adoption of eSanjeevaniOPD in the country, but its post-covid future would largely depend on feature innovation, architecture development, and digital strategies. With a total of three million teleconsultations in one year, eSanjeevaniOPD is one of the world’s largest digital healthcare delivery systems. This case provides insight into Indian health infrastructure, summarizes the journey of eSanjeevaniOPD, and raises questions on the digital transformation of the Indian healthcare delivery system.

Validation of Cardiovascular End Points Ascertainment Leveraging Multisource Electronic Health Records Harmonized Into a Common Data Model in the ADAPTABLE Randomized Clinical Trial

Background: The ADAPTABLE trial (Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-Term Effectiveness) is the first randomized trial conducted within the National Patient-Centered Clinical Research Network to use the electronic health record data formatted into a common data model as the primary source of end point ascertainment, without confirmation by standard adjudication. The objective of this prespecified study is to assess the validity of nonfatal end points captured from the National Patient-Centered Clinical Research Network, using traditional blinded adjudication as the gold standard. Methods: A total of 15 076 participants with established atherosclerotic cardiovascular disease were randomized to two doses of aspirin (81 mg and 325 mg once daily). Nonfatal end points (hospitalization for nonfatal myocardial infarction, nonfatal stroke, and major bleeding requiring transfusion of blood products) were captured with the use of programming algorithms applied to National Patient-Centered Clinical Research Network data. A random subset of end points was independently reviewed by a disease-specific expert adjudicator. The positive predictive value of the programming algorithms were calculated separately for end points listed as primary and as nonprimary diagnoses. Results: A total of 225 end points were identified (91 myocardial infarction events, 89 stroke events, and 45 bleeding events), including 142 (63%) that were listed as primary diagnoses. Complete source documents were missing for 14% of events. The positive predictive value were 90%, 72%, and 93% for hospitalizations for myocardial infarction, stroke, and major bleeding, respectively, as compared to adjudication. When only primary diagnoses were considered, positive predictive value were 93%, 91%, and 97%, respectively. When only nonprimary diagnoses were considered, positive predictive value were 82%, 36%, and 71%. Conclusions: As compared with blinded adjudication, clinical end point ascertainment from queries of the National Patient-Centered Clinical Research Network distributed harmonized data was valid to identify hospitalizations for myocardial infarction in ADAPTABLE. The proportion of contradicted events was high for hospitalizations for bleeding and strokes when nonprimary diagnoses were analyzed, but not when only primary diagnoses were considered.

A Register-Based Study: Cough - A Frequent Phenomenon in the Adult Population

BackgroundChronic cough, more than 8 weeks, can either be without co-morbidity called unexplained chronic cough (UCC) or with co-morbidity called refractory chronic cough (RCC). Using datasets from the Danish National Prescription Registry (Prescription Registry) and Danish National Patient Registry (Patient Registry) we wanted to investigate the prevalence of cough in a Nationwide registry from both primary and secondary care setting.Material and MethodsInclusion criteria were patients 18-90 years with at least one final cough diagnosis (ICD-10 DR05/DR059) in Patient registry or patients who have redeemed ≥2 prescriptions for relevant cough-medication within a 90-day harvest in the Prescription registry from 2008-2017. To validate this study’s chosen proxy on chronic cough an analysis of the Patient registry sub-population with a contact of ≥8 weeks and then final diagnosis code DR05/DR059 was also performed. The population was divided into UCC and RCC.ResultsOf the 104.216 patients from the Prescription registry, 52.727 were classified as having UCC and 51.489 were classified with RCC. From the Patient registry 34.260 were included, of whom 12.278 had UCC and 21.982 had RCC. Cough were frequently found among females between 50 and 66 years. Spirometry was performed in 69% and 57%, X-ray in 73% and 58% and asthma challenge test performed in 13% and 5% (UCC and RCC, respectively). The frequency of co-morbidities such as heart failure, rheumatologic disease, pulmonary embolism, and diabetes was < 10%. The distribution of all the included variables of patients who have had attachment to the department for 8 weeks or more, was similar as in the main group, thus fewer.ConclusionMany patients suffer from chronic cough or cough requiring medications, with or without co-morbidity; frequently found among menopausal women. Most patients had a substantial work-up performed. The high frequency and the resources consuming work-up program call for systematic coding of disease, systematic patient evaluation and more specific treatment options.The study was accepted by the Danish Data Protection Agency (ID: no. P-2019-191)