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PROspective Prostate Cancer Infrastructure: study protocol for the ProPCI 'trials within cohorts study

Por: Wissing · R. O. · van Elst · T. · Sedelaar · M. · Smeenk · R. J. · van den Berg · P. · van Dodewaard-de Jong · J. M. · Lont · A. P. · Hendriks · M. P. · Luijendijk-de Bruin · D. · van de Luijtgaarden · A. C. M. · Roelofs · L. A. J. · Vis · A. N. · Hoekstra · R. J. · Bloemendal · H
Introduction

The diagnostic and therapeutic landscape for high-risk localised prostate cancer and synchronous metastatic hormone-sensitive prostate cancer (mHSPC) is rapidly evolving, driven by advances in imaging, risk stratification and systemic therapies, including the advent of precision medicine. High-quality real-world data integrating clinical, imaging, molecular, quality-of-life information and outcome data remain scarce. The PROspective Prostate Cancer Infrastructure (ProPCI) is a nationwide, multicentre observational cohort designed to collect comprehensive longitudinal data and biomaterials to support real-world evidence generation, facilitate biomarker discovery and enable future cohort multiple randomised controlled trials (cmRCTs).

Methods and analysis

ProPCI includes adult men with high-risk localised prostate cancer or synchronous mHSPC across hospitals in the Netherlands. Clinical data are extracted from electronic health records using a standardised protocol and linked to national registries and healthcare use datasets. Patient-reported outcome measures are collected at baseline and regular intervals using validated instruments. Serial blood samples are biobanked for circulating tumour DNA and other molecular analyses. Outcomes include diagnostic and treatment patterns, Prostate-specific antigen kinetics, time to castration-resistant prostate cancer, radiological and clinical progression, health-related quality of life trajectories and healthcare use, including expenditure and exploratory biomarker associations. Statistical methods include descriptive analyses, time-to-event models, mixed-effects models and biomarker-outcome correlates.

Ethics and dissemination

Ethical approval has been obtained from the Committee on Research Involving Human Subjects (CMO) of Radboudumc. Written informed consent will be obtained from every participating patient and covers: (1) extraction and linkage of clinical, imaging, pathology and registry data, (2) future contact for potential cmRCT participation; and optional components (3) quality-of-life questionnaires, (4) collection of additional blood samples and (5) use of biomaterials for genomic testing. Results will be disseminated through peer-reviewed publications.

Trial registration number

NCT07560748.

Enacting the Nurse–Client Relationship: A Qualitative Study of Older Adults and Community Nurses in Long‐Term Community Care

ABSTRACT

Introduction

The foundation of nursing care is the nurse–client relationship. The Fundamentals of Care (FoC) Framework provides guidance on the core elements of this relationship: trust, focus, anticipate, know, and evaluate. A gap remains in understanding how older adults and nurses themselves engage with these relational elements in the context of long-term community care. This may hinder nurses and their clients from collaborating in care practices.

Aim

To explore how older adults and nurses, through and within their ongoing relationship in community care, concretely enact and co-construct the five elements of the nurse–client relationship and explore factors influencing this relationship.

Design

A qualitative descriptive research design was employed in 2022–2023, utilizing both individual and group interviews. Thirteen unique clients and relatives as informal care givers and 22 nurses participated.

Results

‘Trust’ related to clients trusting the nurses' expertise and nurses enabling clients to feel confident and safe. ‘Focus’ was understood as a shared aim and actions towards maintaining independency and autonomy of clients. ‘Anticipate’ was characterized by nurses responding to clients' preferences and needs and clients and nurses making shared decisions regarding care. ‘Know’ was aimed at gaining a good understanding of clients' needs, which required clients to be open and committed to telling their needs, and nurses actively listening to their clients. Finally, ‘evaluate’, both formal and informal, revealed to be necessary to align and adjust care when necessary. Poor care coordination and continuity of care were contextual factors influencing the caring relationship.

Conclusion

We showed that nurses and clients in community care settings were engaged in a constructive relationship to collaborate for optimal nursing care. An empirical understanding was obtained about how the core elements of this relationship were put into practice. These elements develop over time, influenced by the nurse–client interaction and the specific context.

Implications for the Profession and/or Patient Care

This study highlights that both the client and the nurse have an active role in establishing the nurse–client relationship.

Impact (Addressing)

What problem did the study address? This study addressed how older adults and nurses themselves engage with the relational elements of trust, focus, anticipate, know, and evaluate in the context of long-term community care. What were the main findings? An empirical understanding was obtained of how nurses and clients put these relational elements into practice. These elements evolve over time, influenced by nurse–client interactions and specific contexts. Where and on whom will the research have an impact? This research will impact community-care nurses by offering them practical insights into establishing effective relationships with clients and engaging in dialogue about clients' responsibilities in shaping these relationships.

Reporting Method

We adhered to the Consolidated criteria for reporting qualitative research (Coreq) guidelines (International Journal for Quality in Health Care, 2007, 19, 349).

Patient or Public Contribution

In the research team, two co-researchers (J.A. and J.Z.) participated in the design of the study, data collection and analyses. These co-researchers are older women with experiences in participating in qualitative research (collecting and analysing data) and community-based nursing care (as informal care giver).

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