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Assessment of the integrity of real-time electronic health record data used in clinical research

by Jessica Liu, Sameer Pandya, Andreas Coppi, H. Patrick Young, Harlan M. Krumholz, Wade L. Schulz, Guannan Gong

Background

Near real-time electronic health record (EHR) data offers significant potential for secondary use in research, operations, and clinical care, yet challenges remain in ensuring data quality and stability. While prior studies have assessed retrospective EHR datasets, few have systematically examined the integrity of real-time data for research readiness.

Methods

We developed an automated benchmarking pipeline to evaluate the stability and completeness of real-time EHR data from the Yale New Haven Health clinical data warehouse, transformed into the OMOP common data model. Twenty-nine weekly snapshots of the EHR collected from July to November 2024 and twenty-two daily snapshots collected from April to May 2025 were analyzed. Benchmarks focused on (1) clinical actions such as patient additions, deletions, and merges; (2) changes in demographic variables (date of birth, gender, race, ethnicity); and (3) stability of discharge information (time and status). A synthetic dataset derived from MIMIC-III was used to validate the benchmarking code prior to large-scale analyses.

Results

Benchmarking revealed frequent updates due to clinical actions and demographic corrections across consecutive snapshots. Demographic changes were most frequently related to race and ethnicity, highlighting potential workflow and data entry inconsistencies. Discharge time and status values demonstrated instability for several days post-encounter, typically reaching a stable state within 4–7 days. These findings indicate that while near real-time EHR data provide valuable insights, the timing of data stabilization is critical for accurate secondary use.

Conclusions

This study demonstrates the feasibility of automated benchmarking to assess the integrity of real-time EHR data and identify when such data become analysis ready. Our findings highlight key challenges for secondary use of dynamic clinical data and provide an automated framework that can be applied across health systems to support high-quality research, surveillance, and clinical trial readiness.

Development of a smart walker for clinical settings: a protocol of an exploratory mixed-methods study

Por: Strutz · N. · Meyer-Feil · T. · Schwesig · R. · Schulze · S. · Gissendanner · H.
Introduction

Mobilisation and mobility in clinical settings are essential to the recovery process after surgery and trauma-related hospital admission. In addition to personal support from physiotherapists and nursing staff, aids such as walkers are applied. Walkers equipped with smart features have the potential to benefit geriatric patients by facilitating routine clinical workflows and, where appropriate, by providing health professionals with information on gait patterns and vital parameters.

The overarching goal of this project is to develop an innovative smart walker for clinical use, guided by three objectives: (a) Identify the feature requirements of the smart walker from the perspectives of patients and health professionals, (b) Co-design the smart walker using a user-centred approach involving older patients, health professionals and clinical engineers and (c) Pilot-test the smart walker in real time with older patients admitted to German clinics.

Methods and analysis

We will employ a three-phased exploratory sequential mixed-methods approach in this project. Phase I explores potentially useful characteristics of a smart walker via a scoping literature review (part 1 of phase I) and a qualitative interview and observational study, including questionnaires on sociodemographic data and technology readiness, involving four to six patients and four to eight nurses and physiotherapists (part 2 of phase I). Phase II focuses on developing and validating a smart walker through a user experience design, with at least three iterative test cycles involving a minimum of three asymptomatic participants and three to seven potential users in each cycle. Phase III comprises a pilot study conducted at a University Hospital in Germany involving at least twelve patients. Data integration takes a data-building approach, combining qualitative and quantitative results in the final analysis to generate a comprehensive understanding and to create and refine insights into the feature needs and use of a smart walker by patients.

Ethics and dissemination

The study was approved by the Ethics Committee of University Medicine Halle, Germany (Approval No. 2025-032; date of approval: 03/04/2025). Study results will be disseminated through peer-reviewed journals and conferences.

PROSPERO registration number

The study protocol was registered at the Open Science Framework Platform (OSF, register number: 10.17605/OSF.IO/CTPF4).

Sex differences in the efficacy, safety and persistence of tofacitinib in patients with rheumatoid arthritis: a post hoc analysis of phase III and long-term extension trials

Por: Strand · V. · Schulze-Koops · H. · Al-Emadi · S. · Kinch · C. D. · Gruben · D. · Germino · R. · Connell · C. A. · Mysler · E.
Objectives

Evaluate tofacitinib efficacy, safety and persistence by sex in rheumatoid arthritis (RA).

Design

Post hoc analyses using data from phase III placebo-controlled randomised controlled trials (ORAL Scan, ORAL Sync and ORAL Standard).

Setting

ORAL Scan, ORAL Sync and ORAL Standard were global, multicentre trials conducted across 111, 114 and 115 sites, respectively.

Participants

The trials enrolled adults with active RA and prior inadequate response to methotrexate (ORAL Scan/ORAL Standard) or ≥1 conventional synthetic or biologic disease-modifying antirheumatic drug (ORAL Sync). Post hoc analyses included 2265 patients (1870 female and 395 male).

Interventions

Patients received tofacitinib 5 mg or 10 mg two times a day, adalimumab or placebo.

Outcome measures

Efficacy outcomes to month 12 included American College of Rheumatology (ACR)20, 50 and 70 responses, Disease Activity Score in 28 joints (DAS28) (erythrocyte sedimentation rate (ESR))-defined low disease activity (LDA) and remission, DAS28 (C reactive protein (CRP)) ≤3.2 and

Results

At baseline, female patients had similar DAS28(CRP and ESR), slightly higher HAQ-DI and lower FACIT-F scores versus male patients (n=395). ORs for active treatments (tofacitinib and adalimumab) versus placebo were generally >1 for ACR20, 50 and 70 responses, DAS28(CRP) ≤3.2 and

Conclusions

In post hoc analyses, tofacitinib was efficacious across both sexes, with higher responses in males observed particularly for more stringent composite endpoints and patient-reported outcomes. Findings are generally consistent with studies of other advanced RA therapies. Safety and persistence were similar across sexes. Interpretation is limited by the small proportion of male patients (

Trial registration number

NCT00847613, NCT00856544, NCT00853385, NCT00661661 and NCT00413699.

Improving communication to enhance health literacy and self-management of heart failure: protocol for a multimethod study

Por: Karimi · N. · De Toni · F. · Abhayaratna · W. · Askelin · B. · Currie · P. · Edge · K. · Etherton-Beer · C. · Fewster · E. · Goncharov · L. · Jijo · N. · Macqueen · S. · Mckay · N. · Raine · S. · Rashidi · A. · Rouen · C. · Saunders · R. · Schulz · P. · Tecson · R. · Slade · D.
Introduction

Self-care plays a pivotal role in the management of heart failure (HF). Health literacy and empowerment are considered the prerequisites of effective self-care. This project aims to improve self-management in people with HF by describing, analysing and enhancing the communication practices of clinicians and patients to support people with HF to increase their health literacy skills and participate in shared decision-making.

Methods and analysis

A multimethod research design incorporating an interview component, a concurrent mixed-methods component and a pilot intervention study is used. The study is currently being conducted at two Australian hospitals in metropolitan areas (one public and one private). The interview component involves semistructured interviews with healthcare providers and hospital executives and managers at the participating sites to explore perceived barriers and facilitators to HF self-management and understand the institutional context of HF care. The concurrent mixed-methods components include: (a) tracking and audio recording the clinical interactions of patients with HF (n=30) during their hospitalisation and up to 6 months after discharge and semistructured interviews with the patient (and the carer) and the participating clinician after each clinical interaction and (b) collecting longitudinal survey data (n=180, patients) to track patients’ health literacy, empowerment and self-management over 6 months. The pilot feasibility study includes developing a complex intervention for clinicians and patients and evaluating its acceptability and potential in improving health literacy and reducing readmissions, length of stay and costs.

Ethics and dissemination

This study was approved by the Australian Capital Territory Health (2023.ETH.00007) and Edith Cowan University (023–04314-SAUNDERS) Human Research Ethics Committees. Informed consent was obtained and will continue to be sought from all participants. Study results will be disseminated in peer-reviewed journals.

Frequencies and predictors of missing values as an indicator of data quality in a large population-based sample: an analysis of baseline data from the Hamburg City Health Study

Por: Wiessner · C. · Freitag · J. · Becher · H. · Härter · M. · von dem Knesebeck · O. · Petersen · E. L. · Stahlmann · K. · Briken · P. · Schulz · H. · Bleich · C.
Objective

Data quality in epidemiological studies is a basic requirement for good scientific research. The aim of this study was to examine an important indicator of data quality, data completeness, by investigating predictors of missing data.

Methods

Baseline data of a cohort study, the population-based Hamburg City Health Study, were used. Missingness was investigated at the levels of a whole research unit, on the two segments of health service utilisation and psychosocial variables, and two sensitive items (income and number of sexual partners). Predictors for missingness were sociodemographic variables, cognitive abilities and the mode of data collection. Associations were estimated using binary and multinomial logistic regression models.

Results

Of 10 000 participants (mean age=62.4 years; 51.1% women), 32.9% had complete data at the unit level, 66.8% had partially missing data and 0.3% missed all items. The highest proportions of missing values were found for income (27.8%) and the number of sexual partners (36.7%). At both the unit, segment and item level, older age, female sex, low education, a foreign mother language and cognitive impairment were significant predictors for missingness.

Conclusion

For analysing population-based data, dealing with missingness is equally important at all levels of analysis. During the design and conduct of the study, the identified groups may be targeted to reach higher levels of data completeness.

Qualitative study on doctors perceived barriers and facilitators towards the practice of delayed prescription: results from focus group discussions in Switzerland

Por: Rinaldi · A. · Petrocchi · S. · Bullo · A. · Gabutti · L. · Schulz · P.
Objectives

Antimicrobial resistance is one of the biggest threats posed to healthcare systems, accounting for hundreds of thousands of deaths worldwide and correlated with poorer health status and increased healthcare costs. The practice of delayed prescription seems to be an effective solution to diminish the unnecessary overprescription of antibiotics, as study results demonstrated that it does not negatively affect health status while engaging patients and addressing their desire for a prescription when visiting the doctor’s office. This study investigates the point of view of family doctors practising in Switzerland, a country where delayed prescription has not yet been introduced. The main scope was to describe the perceived barriers and facilitators towards delayed prescription of antibiotics.

Design

A total of five online focus group discussions.

Setting

Family medicine.

Participants

21 family doctors practising in the Italian-speaking region of Switzerland (M=51.24; SD=9.73 years of age; 62% males).

Results

Focus group discussions revealed a generally negative attitude towards delayed antibiotic prescription among participants. Thematic analysis identified three key themes reflecting perceived barriers to its implementation: (1) Maintenance of authority through a gatekeeping role, highlighting concerns about preserving professional control over treatment decisions; (2) Importance of maintaining communication, addressing fears that delayed prescription could undermine clarity and trust in doctor–patient interactions and (3) Healthcare system and guidelines for good practice, which encompasses structural and normative expectations around follow-up visits, pre-existing practices and clinical routines. These themes illustrate the multifaceted nature of physicians’ resistance to adopting delayed prescription in their daily practice.

An additional information that emerged from the discussions is the extensive use in the region of a practice similar to delayed prescription, called ‘the stock antibiotic’. However, it is perceived very differently by physicians because it does not enforce a predetermined waiting time on patients.

Conclusions

Past research has demonstrated that delayed prescription is an effective practice for reducing antibiotic consumption and promoting patients’ empowerment while maintaining their satisfaction. Nevertheless, the results of this study show that doctors’ perceptions of this practice are not always positive. Any attempt to introduce the practice should start with a careful evaluation of the cultural context and doctors’ opinions, as their willingness to embrace the practice is crucial for its successful adoption. A more practical implication of our results stems from the discovery of the practice of the stock antibiotic, which could be described as a new version of delayed prescription, tailored to the customs and practices of the region. This aspect highlights the importance of exploring local contexts to ensure that prescribing practices can be implemented in alignment with local preferences.

Distal Radius Interventions for Fracture Treatment (DRIFT) trial: study protocol for a multicentre randomised clinical trial of completely translated distal radius fractures at paediatric hospitals in North America

Por: Balmert Bonner · L. · Janicki · J. · Georgiadis · A. · Truong · W. · Harris Beauvais · D. · Belthur · M. · Daley · E. L. · Franzone · J. · Howard · A. · May · C. · Rockhold · F. · Schulz · J. · Bailey · M. · Chiswell · K. · DeLaRosa · J. · Brooks · J. T. · Cantanzano · A. A. · Chan · A.
Introduction

Distal radius fractures are the most common fractures seen in the emergency department in children in the USA. However, no established or standardised guidelines exist for the optimal management of completely displaced fractures in younger children. The proposed multicentre randomised trial will compare functional outcomes between children treated with fracture reduction under sedation versus children treated with simple immobilisation.

Methods and analysis

Participants aged 4–10 years presenting to the emergency department with 100% dorsally translated metaphyseal fractures of the radius less than 5 cm from the distal radial physis will be recruited for the study. Those patients with open fractures, other ipsilateral arm fractures (excluding ulna), pathologic fractures, bone diseases, or neuromuscular or metabolic conditions will be excluded. Participants who agree to enrol in the trial will be randomly assigned via a minimal sufficient balance algorithm to either sedated reduction or in situ immobilisation. A sample size of 167 participants per arm will provide at least 90% power to detect a difference in the primary outcome of Patient-Reported Outcomes Measurement Information System Upper Extremity computer adaptive test scores of 4 points at 1 year from treatment. Primary analyses will employ a linear mixed model to estimate the treatment effect at 1 year. Secondary outcomes include additional measures of perceived pain, complications, radiographic angulation, satisfaction and additional procedures (revisions, refractures, reductions and reoperations).

Ethics and dissemination

Ethical approval was obtained from the following local Institutional Review Boards: Advarra, serving as the single Institutional Review Board, approved the study (Pro00062090) in April 2022. The Hospital for Sick Children (Toronto, ON, Canada) did not rely on Advarra and received separate approval from their local Research Ethics Board (REB; REB number: 1000079992) on 19 July 2023. Results will be disseminated through publication in peer-reviewed journals and presentations at international conference meetings.

Trial registration number

NCT05131685.

Incidence of type 2 diabetes by socioeconomic deprivation in Germany between 2014 and 2019: an ecological study

Por: Piedboeuf-Potyka · K. · Hering · R. · Schulz · M. · Mackowiak · M. · Brinks · R. · Kuss · O. · Hoyer · A. · Tönnies · T.
Objective

To estimate type 2 diabetes incidence trends by sex and socioeconomic position (SEP) and evaluate trends in SEP-related inequalities in incidence.

Design

Ecological study using ambulatory claims data and regression-based modelling.

Setting

All 401 counties in Germany, covering the entire country.

Participants

All individuals with statutory health insurance (~85% of the population). Incident cases of type 2 diabetes were identified annually from 2014 to 2019 using the International Statistical Classification of Diseases and Related Health Problems, 10th revision codes.

Primary and secondary outcome measures

Incident type 2 diabetes at the county level, adjusted for age and modelled using a mixed negative binomial regression. SEP was measured using the German Index of Socioeconomic Deprivation, and a random intercept accounted for county-level heterogeneity.

Results

The incidence of type 2 diabetes decreased between 2014 and 2017 and plateaued thereafter. Trends were similar between sexes and deprivation levels. The greatest difference was observed between high and low deprivation, with an incidence rate ratio of 1.20 (95% CI: 1.14 to 1.27) among men and 1.21 (95% CI: 1.14 to 1.27) among women in 2014.

Conclusions

There was a positive trend in the decline in age-adjusted type 2 diabetes incidence between 2014 and 2019. However, social inequality persisted with deprived groups at higher risk of type 2 diabetes. The level of inequality was comparable between men and women. Continued monitoring is essential to assess whether these short-term trends persist over time.

Prevalencia de los cambios dermatológicos en personas diabéticas con ulceración del pie

Objetivo principal: Estimar la prevalencia de alteraciones dermatológicas en personas diabéticas con ulceración del pie atendidas en un centro de referencia en diabetes en Bahía. Metodología: Estudio transversal y retrospectivo. La población del estudio consistió en 133 pacientes tratados en 2017 y la recopilación de datos tuvo lugar entre agosto y octubre de 2018. Para el análisis de datos se utilizaron estadísticas descriptivas realizadas utilizando el software estadístico Statistical Package for the Social Sciences (SPSS 16.0). Resultados principales: El cambio más frecuente fue la callosidad (48,1%) seguido de xeroderma (47,4%), micosis interdigital (18%), onicomicosis (13,5%), fisuras (6,8%). Entre el momento del diagnóstico de diabetes y fisuras se encontraron asociaciones entre el momento del diagnóstico de diabetes y fisuras (p= 0,019), úlcera neuropática y xeroderma (p=0,015), úlcera infectada y callos o callos (p=0,010). La onicomicosis y el xeroderma eran más frecuentes en los hombres, mientras que los callos en las mujeres. Conclusión principal: En esta investigación se encontraron nuevas asociaciones. Se observó que la salud de los pies es una brecha en la literatura y este estudio tiene como objetivo ampliar el conocimiento sobre este tema, sirviendo para guiar los comportamientos de atención al paciente en los servicios y calificar la atención médica de las personas diabéticas.

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