Innovative Real-World Data Use for Identifying Stroke Survivors and Access to Rehabilitation in Primary Care in Brazil

Stroke, Ahead of Print. BACKGROUND:As the impact of stroke remains, primary healthcare will continue to be a critical platform managing the poststroke journey. We aimed to identify stroke survivors assisted by community health worker in Brazil and how they relate to the location of rehabilitation facilities locations.METHODS:We developed a cross-sectional study using deidentified data from a real-world database generated by a free data collection app used by community health workers from May 2015 to January 2021 in Brazil to identify stroke survivors and to assess demographics and clinical characteristics. We used data from a public database, Cadastro Nacional de Estabelecimentos de Saúde, for identifying rehabilitation facilities. Locations were obtained by a geocoding application programming interface (Google Maps Platform), distances were measured in kilometers, and travel time in minutes.RESULTS:Among 2 397 764 individuals assisted by community health workers, 21 785 were stroke survivors, representing a 0.9% prevalence. Among this subgroup, the majority were in the Northeast region (n=10 951; 50.3%) and 16 922 (77.7%) in urban areas. Most individuals (n=11 504; n=142; 52.8%) were women, the mean age was 66.5 (SD, 14.7), and 4313 reported physical disability. In total, 348 rehabilitation facilities were identified, mostly located in the Southeast region (40.8%). The mean distance from stroke survivor to facility was 79.13 km (SD, 97.73; median [1Q, 3Q], 47.64 km [12.19, 107.80 km]), and mean travel time was 81.18 minutes (SD, 85.85). The Southern region recorded the largest mean and median distance (mean 175.58 km; SD, 163.18; median [1Q, 3Q] 88.47 [59.38, 425.38]) to rehabilitation center and the longest mean travel time (144.48 minutes; SD, 112.57; median [1Q, 3Q] 92.34 [60.59, 305.12]).CONCLUSIONS:Despite the availability of rehabilitation centers in Brazil, geographic access as represented by the distances and travel times observed access is still suboptimal. As a means of improving the clinical pathway and resource allocation, the use of large real-world databases and adequate analysis may become a key component for real needs assessments.

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Marzo 2025

Clinical Outcomes With Normothermic Pulsatile Organ Perfusion in Heart Transplantation: A Report From the OCS Heart Perfusion Registry

Circulation, Ahead of Print. BACKGROUND:A preservation system, the Organ Care System (OCS; TransMedics) uses normothermic pulsatile perfusion during organ transport for heart transplantation. This system has demonstrated favorable outcomes in hearts recovered from extended-criteria donors after brain death (DBD) and donors after circulatory death (DCD).METHODS:The OCS Heart Perfusion Registry collects data on US heart transplantations using the OCS, static cold storage (SCS), or thoracoabdominal normothermic regional perfusion (NRP) recovered from DBD or DCD donors. We analyzed donor and recipient characteristics and posttransplantation outcomes in patients transplanted with OCS donor hearts (either DBD or DCD) compared with SCS hearts and OCS hearts from DCD donors compared with those recovered with NRP followed by SCS. Propensity score matching was used in survival analyses to adjust for differences among recipient characteristics.RESULTS:Between 2021 and 2023, 3225 consecutive heart transplantations enrolled from 56 centers were analyzed in the Heart Perfusion Registry. The OCS was used in 854 of 3225 heart transplantations (26.4%), among which 340 (39.8%) were DBD and 514 (60.2%) were DCD donors, whereas 2174 DBD donors were recovered with SCS and another 197 DCD donors with NRP techniques. The OCS-DBD group experienced a greater number of organ offer refusals before final acceptance (13 versus 6; Wilcoxon rank sum,P

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Marzo 2025

2025 ACC/AHA/ACEP/NAEMSP/SCAI Guideline for the Management of Patients With Acute Coronary Syndromes: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines

Circulation, Ahead of Print. Aim:The “2025 ACC/AHA/ACEP/NAEMSP/SCAI Guideline for the Management of Patients With Acute Coronary Syndromes” incorporates new evidence since the “2013 ACCF/AHA Guideline for the Management of ST-Elevation Myocardial Infarction” and the corresponding “2014 AHA/ACC Guideline for the Management of Patients With Non–ST-Elevation Acute Coronary Syndromes” and the “2015 ACC/AHA/SCAI Focused Update on Primary Percutaneous Coronary Intervention for Patients With ST-Elevation Myocardial Infarction.” The “2025 ACC/AHA/ACEP/NAEMSP/SCAI Guideline for the Management of Patients With Acute Coronary Syndromes” and the “2021 ACC/AHA/SCAI Guideline for Coronary Artery Revascularization” retire and replace, respectively, the “2016 ACC/AHA Guideline Focused Update on Duration of Dual Antiplatelet Therapy in Patients With Coronary Artery Disease.”Methods:A comprehensive literature search was conducted from July 2023 to April 2024. Clinical studies, systematic reviews and meta-analyses, and other evidence conducted on human participants were identified that were published in English from MEDLINE (through PubMed), EMBASE, the Cochrane Library, Agency for Healthcare Research and Quality, and other selected databases relevant to this guideline.Structure:Many recommendations from previously published guidelines have been updated with new evidence, and new recommendations have been created when supported by published data.

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Febbraio 2025

Correction: 'Do european regulatory measures accelerate national market access in Belgium? A retrospective analysis of medicines centrally authorised between 2015 and 2020

Claessens Z, Fieuws S, Daems J, et al. Do European regulatory measures accelerate national market access in Belgium? A retrospective analysis of medicines centrally authorised between 2015 and 2020. BMJ Open 2025;15:e091361. doi:10.1136/bmjopen-2024–0 91 361
This article has been corrected since it was published online. Figure 4 of the paper has been updated from (lacking number of medicines included in conditional marketing authorisation)
to (including the number of medicines with conditional marketing authorisation)

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Febbraio 2025

Changes in global quality of life after treatment with immune checkpoint inhibitors in patients receiving different treatment regimens for advanced stage lung cancer in the Netherlands: a 2015-2021 cohort study

Background
The introduction of immune checkpoint inhibitors (ICIs) has modified treatment modalities for patients with lung cancer, offering new alternatives for treatment. Despite improved survival benefits, ICIs may cause side effects impacting patients’ quality of life (QoL). We aim to study the changes in global QoL (gQoL) of patients with advanced-stage lung cancer up to 18 months after treatment with ICIs between 2015 and 2021.

Methods and analysis
A longitudinal cohort study was conducted using the Oncological Life Study: Living well as a cancer survivor data-biobank from the University Medical Center Groningen. Participants completed the European Organisation for Research and Treatment of Cancer QoL 30-item questionnaire, at the beginning of their ICI treatment (baseline) and then at 6, 12 and 18 months. Using joint modelling, changes in predicted mean gQoL were studied by treatment regimens from baseline to 18 months, while accounting for the competing risk of death and adjusting for prespecified covariates.

Results
Of the 418 participants with median age of 66 years, 39% were women. Patients receiving first-line immuno-monotherapy with palliative intent had a small improvement in their gQoL within 6 months and no clinically significant change thereafter. Patients receiving first-line immune-chemotherapy with palliative intent had a small improvement in their gQoL within 12 months and no clinically significant change thereafter. Patients with second/further line immunotherapy with palliative intent or first-line chemoradiotherapy followed by durvalumab with curative intent had no clinically significant change in their gQoL over 18 months.

Conclusion
The changes in gQoL over time among patients with advanced-stage lung cancer may vary by treatment regimens based on drug intensity, line and intent of treatment, which will help clinicians and patients understand the potential dynamic of treatments on QoL. It may further influence treatment decisions and patient management strategies, reflecting the practical implications of different treatment regimens.

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Febbraio 2025

Blood Biomarkers to Detect Alzheimer Disease

To the Editor In their excellent research, Dr Palmqvist and colleagues report high diagnostic accuracy of blood biomarkers in the diagnosis of Alzheimer disease. The authors used the STROBE checklist for observational studies, but this is a prospective diagnostic accuracy study, for which the STARD checklist is more appropriate.

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Febbraio 2025

Co-creating tools for embedding meaningful patient and public involvement and engagement in real-world data and evidence research in the pharmaceutical industry setting: a multistakeholder participatory co-design study

Objectives
This study aimed to (1) gauge patients understanding and expectations of real-world data and evidence (RWDE) research and (2) use this understanding and patients lived experience to co-create resources and a framework for embedding meaningful patient and public involvement and engagement (PPIE) in RWDE research within the pharmaceutical industry setting.

Setting and participants
An academic organisation, a pharmaceutical company and a PPIE panel of 12 patients or carers partnered to form the project team. The PPIE panel was purposively selected to maximise diversity.

Design
Participatory and co-design methods were used to engender an understanding of the PPIE perspective on RWDE research and the PPIE role within that. Interactive workshops explored understanding and expectations of RWDE research as well as perceived barriers and facilitators of PPIE within each stage of the RWDE research cycle. Workshops were audio and video recorded, with notes captured. Summaries were analysed thematically and shared back with the PPIE panel for validation and further reflection.

Results
We identified a lack of trust and understanding of real-world data, its collection and use and the need to educate the public and researchers. Four themes were identified for meaningful PPIE in RWDE research; equality, diversity and inclusion; feeling valued; ownership and understanding and evaluating impact. We co-created learning resources (video, infographic) and a novel PPIE framework, incorporating potential PPIE activities, resources and support needs for use by researchers conducting RWDE research.

Conclusions
To our knowledge, this is the first project to explore the practicalities of PPIE in RWDE research from the perspective of patients and carers. Some findings confirm PPIE experience and guidance derived from other areas, with some specific insights into the pharmaceutical industry. These underpin the PPIE framework to enable robust and meaningful PPIE in RWDE research. This article includes a plain language summary in the supplement.

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Febbraio 2025