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Effect of supplemental hydrocortisone during stress in prednisolone-induced adrenal insufficiency: a study protocol for a multicentre, randomised, double-blinded, placebo-controlled clinical trial on health-related quality of life in patients with polymya

Por: Borresen · S. W. · Hansen · S. B. · Al-Jorani · H. · Tei · R. · Dreyer · A. F. · Boesen · V. B. · Bislev · L. S. · Jorgensen · N. T. · Jensen · R. C. · Bjergstrom · M. L. L. · Christensen · L. L. · Frederiksen · J. S. S. · Glintborg · D. · Bjorner · J. B. · Feldt-Rasmussen · U. · Jor
Introduction

Patients on low-dose prednisolone may develop adrenal insufficiency causing reduced health-related quality of life (HRQoL) and increased risk of adrenal crisis. This study examines whether supplemental hydrocortisone during mild to moderate stress improves HRQoL in patients with polymyalgia rheumatica/giant cell arteritis (PMR/GCA) with adrenal insufficiency on low-dose prednisolone.

Methods and analysis

A multicentre, randomised, double-blinded, placebo-controlled, clinical trial including patients with PMR/GCA receiving ongoing prednisolone ≤5 mg/day. Eligible patients undergo an adrenocorticotropic hormone (ACTH) test, and 250 patients with a stimulated cortisol

Ethics and dissemination

The study is approved by the Ethics Committee of the Capital Region of Denmark and the Danish Medicines Agency. Recruitment began June 2022. The last patient’s last visit is expected in 2026. Results will be disseminated via peer-reviewed publication and conference presentations.

Trial registration numbers

EudraCT:2021-002528-18, CTIS:2024-518272-30-00, NCT05435781.

The Power of a Ricoeur‐Inspired Phenomenological‐Hermeneutic Approach to Focus Group Interviews

ABSTRACT

Aim

To justify the use of focus group interviews with patients and healthcare professionals within a phenomenological-hermeneutic approach inspired by the theory of the French philosopher Paul Gustave Ricoeur.

Design and Methods

Methodological guidance and discussion grounded in Ricoeur's theory on narrative, dialogue, threefold mimesis and interpretation.

Results

This phenomenological-hermeneutical approach to focus group interviews yields significant, in-depth understandings of lived experiences from both patients and healthcare professionals.

Conclusions

Ricoeur-inspired phenomenological-hermeneutical focus group interviews with patients and healthcare professionals offer a promising approach for exploring and generating new, valuable insights into the complexities of clinical nursing practice. Thus, this paper argues for an integration of focus group interviews and a phenomenological-hermeneutical approach within nursing science.

Implications for the Profession

The approach has significant implications for nursing practice. By incorporating Ricoeur-inspired dialogue-based collective voices of patients and healthcare professionals in focus group interviews, nursing practices can be refined, leading to improved patient care and more effective clinical interventions. Thus, this approach advocates for a broader adoption of Ricoeur-inspired focus group interviews in nursing research and in health research in general to enhance the understanding and development of clinical models.

Reporting Method

No available EQUATOR guidelines were applicable to this methodological paper, as no new data were created or analysed.

Patient or Public Contribution

As this is a methodological paper, no new patient or public contributions are included.

Hydrocortisone replacement therapy in patients with glucocorticoid withdrawal syndrome after cessation of glucocorticoid treatment: REPLACE, a multicentre, randomised, double-blinded, placebo-controlled, 16-week study protocol

Por: Dreyer · A. F. · Hansen · S. B. · Borresen · S. W. · Al-Jorani · H. · Bislev · L. S. · Boesen · V. B. · Christensen · L. L. · Glintborg · D. · Jensen · R. C. · Jorgensen · N. T. · Klose · M. C. · Lund · M. L. · Frederiksen · J. S. S. · Tei · R. · Feldt-Rasmussen · U. · Jorgensen · J.
Introduction

Glucocorticoid therapy is prescribed for a variety of inflammatory conditions and is associated with severe adverse effects. A glucocorticoid withdrawal syndrome (GWS) may occur after prolonged glucocorticoid treatment—with or without biochemical glucocorticoid-induced adrenal insufficiency (GIAI). Previously, GWS was not considered an entity, probably due to the overlap between symptoms of GWS and GIAI. The Addison’s disease-specific quality of life questionnaire (AddiQoL-30) is a validated tool for quantifying symptoms of adrenal insufficiency resembling GWS. In the present study, we test the hypothesis that patients with a low AddiQoL-30 score and/or low cortisol response to a short Synacthen test (SST), after cessation of prednisolone treatment, may benefit from low-dose hydrocortisone therapy without increasing the risk of metabolic and cardiovascular disease during prolonged cortisol exposure.

Methods and analysis

REPLACE is a multi-centre, double-blinded, placebo-controlled randomised controlled trial in patients with polymyalgia rheumatica or giant cell arteritis after cessation of prednisolone treatment. Criteria for randomisation are an AddiQoL-30 score ≤85 and/or plasma cortisol response to SST, 30-min p-cortisol >100 and 85; and (2) patients with a SST-stimulated cortisol ≤100 nmol/L.

Ethics and dissemination

The study is conducted in accordance with the Declaration of Helsinki, registered at the Clinical Trials Information System (CTIS: 2024-513822-53-00) and Clinicaltrials.gov (NCT05193396), and publications will be in accordance with the recommendations of the International Committee of Medical Journal Editors. The trial is monitored by local independent Good Clinical Practice units and overseen by the Danish Data Protection Agency (journal no. 21/27119), the Regional Committees on Health Research Ethics for Southern Denmark (project ID: S-20210076), the Danish Patient Safety Authority and the Danish Medicines Agency.

Trial registration number

NCT05193396.

Advance Care Planning During Healthcare Transitions for Community‐Dwelling Older Adults in Their End of Life: A Scoping Review

ABSTRACT

Background

Older adults often experience unplanned hospital admissions at the end of life, which may conflict with their wish to remain at home. Advance care planning (ACP) can help align care with patient preferences, but timely discussions and documentation are often lacking. Effective communication across healthcare settings is therefore essential.

Aim

To explore how ACP is delivered for community-dwelling older adults, focusing on intervention components, communication during care transitions and related barriers and facilitators.

Design

A scoping review conducted according to Joanna Briggs Institute methodology and reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) guidelines.

Methods

We systematically searched six databases (PubMed, Embase, CINAHL, PsycINFO, Scopus and Web of Science) on 7 April 2025 for peer-reviewed primary studies on ACP interventions for community-dwelling older adults during healthcare transitions. Data were extracted using a structured table.

Results

Sixteen studies from seven countries (2016–2024) were included, with most conducted in the United States. ACP interventions typically involved healthcare professional education, structured documentation and coordination across settings. Communication strategies included written records, discharge summaries, telephone calls, face-to-face meetings and electronic systems. Key facilitators were timely patient identification, GP involvement, clear role distribution and use of existing clinical structures. Barriers included time constraints, unclear responsibilities, fragmented communication, insufficient training and emotional reluctance. ACP was often deprioritised due to acute care episodes.

Conclusion

ACP for community-dwelling older adults is a complex intervention challenged by structural, organisational and relational barriers. Future research should explore sustainable, context-sensitive ACP models that emphasise long-term integration, patient experiences and diverse care settings.

Patient or Public Contribution

No patient or public contribution.

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