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Ayer — Octubre 14th 2025Tus fuentes RSS

Economic evaluation of a person-centred care intervention with a digital platform and structured telephone support for people with chronic heart failure and/or chronic obstructive pulmonary disease: results from a randomised controlled trial in Sweden

Por: Harvey · B. P. · Barenfeld · E. · Fors · A. · Ekman · I. · Swedberg · K. · Gyllensten · H.
Objectives

The aim of the study was to evaluate the healthcare costs and effects of a remote person-centred care (PCC) add-on intervention compared with usual care for people with chronic heart failure (CHF) and/or chronic obstructive pulmonary Disease (COPD) from a societal perspective.

Design

A cost-effectiveness analysis (CEA) based on the results from a randomised controlled trial.

Setting

The study was conducted from August 2017 until June 2021 within nine primary care centres across Western Sweden.

Participants

Participants in the study had a diagnosis of COPD (J43.0, J44.0–J44.9) and/or CHF (I50.0–I50.9).

224 patients were randomly allocated to the study groups. After two withdrawals, the final intention-to-treat analysis included 110 participants in the intervention group and 112 in the control group.

Interventions

Both the intervention and control group received usual care through their primary care centres. In addition, the intervention group participated in a remote PCC add-on intervention consisting of a digital platform and structured telephone support.

Primary outcome

Incremental cost-effectiveness ratio using direct healthcare costs, productivity loss and prescription drug costs, compared with health effects measured using the EuroQoL questionnaire (EQ-5D-3L) over a 2-year time horizon.

Results

The intervention group had lower healthcare utilisation in inpatient care, specialised outpatient care and reduced productivity loss. The CEA showed incremental effects of 0.0469 quality-adjusted life years and incremental costs of SEK –68 533 (Swedish crowns). The PCC alternative was both more effective and resulted in lower healthcare costs compared with usual care, that is, PCC was dominant.

Conclusions

The results of this CEA demonstrated that a remote PCC add-on intervention for people with COPD and/or CHF had lower healthcare costs and higher health-related quality of life compared with usual care.

Trial registration number

NCT03183817 ClinicalTrials.gov.

Patient and healthcare professional engagement and time use within a randomised controlled trial: investigating intervention costs associated with remote person-centred care in Sweden

Por: Barenfeld · E. · Ekman · I. · Cederberg · M. · Fors · A. · Ali · L. · Gyllensten · H.
Objectives

To describe the usage patterns of patients and healthcare professionals (HCPs) using a person-centred telehealth and e-health intervention.

Design

An exploratory, descriptive, observational study embedded in the "Person-centred care at a distance (PROTECT)" randomised controlled trial (ClinicalTrials.gov: NCT03183817) as part of a process evaluation. Data on intervention use and time spent on the intervention were collected. Descriptive statistics were calculated.

Setting

Participants were recruited from nine public primary healthcare facilities located in various areas of Gothenburg, Sweden.

Participants

110 patients participating in the intervention group in the PROTECT trial were included. Participants were diagnosed with chronic heart failure (CHF, n=42), chronic obstructive pulmonary disease (COPD, n=56) or both (n=12). They were 33–93 years old (mean 71 years).

Primary and secondary outcome measures

A secondary outcome report on resource use.

Intervention

The 6-month-long intervention was performed as an add-on to standard care and comprised person-centred telephone support and access to a digital platform. Per-protocol use included co-creation of a health plan via the telephone and use of the digital platform at least once. Forms of use were tailored to the preferences and needs of the patients.

Results

Most intervention activities took place in the first 3 months of the intervention. Most patients used a combination of phone and digital support, spending most of their time using the digital platform. Overall, patients and HCPs spent 6 and 2.5 hours/patient using the intervention, respectively. Of this time, 1.5 hours involved synchronous communication through phone calls, with health-plan calls averaging 77 min.

Conclusions

The intervention usage patterns of patients and HCPs differed. Despite HCPs being accessible when required, patients dedicated most of their time to self-care practices. Based on time distribution data, 15 full-time HCPs could potentially co-create, document and follow-up on health plans for 10 000 patients under study conditions.

Trial registration number

ClinicalTrials.gov: NCT03183817.

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New regimens of benznidazole for the treatment of chronic Chagas disease in adult participants in indeterminate form or with mild cardiac progression (NuestroBen study): protocol for a phase III randomised, multicentre non-inferiority clinical trial

Por: Marques · T. · Forsyth · C. · Barreira · F. · Lombas · C. · Blum de Oliveira · B. · Laserna · M. · Molina · I. · Bangher · M. d. C. · Javier Fernandez · R. · Lloveras · S. · Fernandez · M. L. · Scapellato · P. · Patterson · P. · Garcia · W. · Ortiz · L. · Schijman · A. · Moreira · O. C.
Introduction

Chagas disease (CD) is one of the most neglected diseases in the world. In Latin America, CD is endemic in 21 countries, with an estimated 70 million people at risk of infection. Current treatments are limited to two nitroheterocyclic compounds: nifurtimox and benznidazole (BZN). Each has significant limitations, including long duration and safety concerns. However, data from recently completed studies suggest that reduced-duration regimens may be equally effective while enhancing safety.

Methods and analysis

NuestroBen is a phase III, randomised, multicentre clinical trial designed to assess whether shorter (2- and 4-week) regimens of BZN are non-inferior to the standard 8-week treatment. A total of 540 adult participants with no evidence of organ damage (the indeterminate form) or with mild cardiac progression (mild electrocardiographic alterations and without systolic dysfunction or symptoms), all in the chronic phase of CD, will be recruited at six study sites in Argentina and two study sites in Bolivia. Participants will be randomised to receive one of the two shortened regimens of BZN (300 mg per day for 2 or 4 weeks) or standard treatment (300 mg per day for 8 weeks). The primary endpoint is sustained elimination of parasitaemia from the end of treatment through 12 months of follow-up. Secondary endpoints will assess sustained clearance of parasitaemia at 1, 4, 6 and 8 months of follow-up from the end of treatment, drug tolerability and adherence to treatment. NuestroBen will also evaluate whether two shortened regimens of BZN improve drug tolerability and treatment adherence compared with the current standard treatment while maintaining efficacy in participants with the indeterminate form of CD or with mild cardiac involvement.

Ethics and dissemination

In Argentina, this study was approved by Fundación de Estudios Farmacológicos y Medicamentos ‘Luis M. Zieher’ for its conduct at the Instituto de Cardiología de Corrientes ‘Juana Francisca Cabral’ (reference: NuestroBen-2020/2021) and the Instituto Nacional de Parasitología ‘Dr. Mario Fatala Chaben’ (reference: NuestroBen-2020/2021) by Comité Institucional de Ética de Investigación en Salud for the Centro de Chagas y Patología Regional de Santiago del Estero (reference: NuestroBen-2020-088/2021), by Comité de Ética en Investigación for the Hospital de Infecciosas F.J. Muñiz (reference: NuestroBen-2020–4037) and the Hospital General de Agudos D.F. Santojanni (reference: NuestroBen-2020–4039) and by Comité de Bioética for the Fundación Huésped (reference: NuestroBen-2020/2021). In Bolivia, it was approved by Comité de Ética en Investigación en Salud from the Universidad Autónoma Juan Misael Saracho (reference: NuestroBen-2020/2025). All participants are asked to provide written informed consent to participate. Recruitment processes started in July 2023, and as of 15 June 2025, 140 participants have been recruited. Findings will be shared with Argentinian and Bolivian public health officials and with the Chagas and tropical medicine communities via international conferences. Findings will also be published in medical journals.

Trial registration number

NCT04897516.

Development of methods to identify digitally excluded older people, and tailoring of interventions to meet their digital needs: a protocol for a mixed-methods study (the INCLUDE study)

Por: Brundle · C. · Johansson · J. F. · Best · K. · Clegg · A. · Forster · A. · Atkinson · T. · Foster · M. · Humphrey · S. · Iliff · A. · Inglis · J. · Walker · C. · Graham · L.
Introduction

Digital inclusion (which includes skills, accessibility and connectivity to the internet and digital devices) is a ‘super social determinant of health’ because it affects many aspects of life that influence health. Older people are especially vulnerable to digital exclusion. Existing digital inclusion interventions are commonly offered opportunistically to people who come into contact with services, or in specific locations. The lack of systematic identification of need unintentionally excludes older people who may be most in need of support, and that support is not addressing their needs.

Methods and analysis

This multi-method project includes six workstreams: (1) A survey of people aged 65+ to ask about digital use and engagement. Survey data will be used to develop a model that predicts digital exclusion from data available in primary care records. (2) Testing, via a further survey, the external validity of the model to identify those who are digitally excluded. (3) Interviews with community service providers to identify, understand and define the components of existing digital inclusion services for older people. Concurrently, a rapid review of the literature will identify evidence for interventions aimed at supporting digitally excluded adults aged 65+. (4) Interviews with people aged 65+ representing a range of digital use will explore factors from the COM-B model that influence digital behaviours—their capability (C), opportunity (O) and motivation (M) relating to digital engagement. Analysis outputs will identify the intersectional nature of barriers or facilitators to digital inclusion. (5) Co-production workshops with older people and community service providers will identify key components of interventions that are required to address digital exclusion. Components will be mapped against existing interventions, and the ‘best fit’ intervention(s) refined. An implementation plan will be developed in parallel. (6) Feasibility testing of the refined intervention(s) to assess acceptability and obtain feedback on content and delivery mechanisms.

Ethics and dissemination

This study was approved by the Yorkshire & The Humber - Bradford Leeds Research Ethics Committee on 23 October 2023 (ref. 23/YH/0234). Findings will be disseminated in academic journals and shared at webinars, seminars, conferences and events arranged by organisations operating across the digital inclusion and older people fields.

Trial registration

https://www.isrctn.com/ISRCTN18306736

Developing an Intervention to Improve Sexual Health Assessment and Care in Men With Inflammatory Bowel Disease

ABSTRACT

Aim

To co-produce a prototype intervention to help nurses improve the assessment and care of the sexual health needs of men with inflammatory bowel disease.

Background

Inflammatory bowel disease can have a significant impact on the sexual health and well-being of men, but has largely been neglected in research and clinical guidelines. Men with the disease report that sexual health is not discussed during consultations, while healthcare practitioners describe a lack of confidence to initiate sexual health assessments. At present, no evidence-based tool exists to support nurses in detecting, assessing, and providing care for the sexual health of men with the disease.

Design

A mixed-methods study shaped by phase 1 of the Medical Research Council's framework for the development of complex interventions.

Methods

(1) Cross-sectional surveys of (i) men with inflammatory bowel disease, (ii) nurses, and (iii) inflammatory bowel disease services to determine the current state of sexual health provision across the UK National Health Service. (2) Semi-structured interviews with men and the partners of men with IBD and asynchronous focus groups with health professionals to explore appropriate and acceptable ways to provide sexual healthcare. (3) Three consecutive co-production workshops inclusive of men with the disease, healthcare professionals, and stakeholders to formulate a prototype intervention.

Implications for the Profession and/or Patient Care

This study will create an evidence-based prototype intervention that will provide nurses with the knowledge and skills required to effectively assess the sexual health needs of men with inflammatory bowel disease and provide appropriate, patient-centred care.

Patient Contribution

The study design was supported by a patient group. The study delivery will be supported by a patient co-investigator and stakeholder group inclusive of men with lived experience of the disease.

Reporting Method

This report adheres to the SPIRIT 2013 checklist for standard protocol items for clinical trials.

Trial Registration

clinicaltrials.gov ID: NCT06562751

Understanding tuberculosis among people with tuberculosis through an educational film: a qualitative study

Por: Economou Lundeberg · E. · Biermann · O. · Kuhlin · J. · Kulane · A. · Annerstedt · K. S. · Davies Forsman · L.
Introduction

Treatment of the two billion people with tuberculosis (TB) infection worldwide is crucial to prevent progression to TB disease and thereby prevent further transmission. However, TB is associated with fear and stigma, and knowledge gaps about TB disease are widespread, complicating adherence to treatment. As increasing knowledge about TB can reduce stigma and increase adherence to treatment, we developed an educational film about TB infection and disease. After showing the film to people with TB, our qualitative study aimed to evaluate the film and to explore perceptions, fears and possible knowledge gaps.

Method

We conducted a qualitative study, with in-depth interviews (n=13), at two Infectious Disease Outpatient Departments in Sweden. Included research participants were adults with TB infection or TB disease. After informed consent, the participants watched the film, available in Swedish, English, Somali and Tigrinya. Subsequently, in-depth interviews, using a topic guide, were conducted, transcribed, and a reflexive thematic analysis was performed.

Results

All participants considered the film to be a valuable addition to the written and oral information they had previously received. Identified themes included the perception of TB infection being a deadly, non-curable disease, and many feared being contagious. However, the film challenged these fears and increased the understanding of TB infection being treatable and non-infectious. Another theme revealed that TB-related stigma was experienced in encounters with healthcare professionals in Sweden.

Conclusion

Our educational film was perceived to increase understanding about TB symptoms, transmission and treatment. Implementing the film in Infectious Disease Departments across Sweden may contribute to decreasing stigma and enhancing awareness of the importance of treatment adherence, an outcome that warrants further investigation post-implementation.

Stoma Care Nurse Consultations Regarding Leakages and Peristomal Skin Complications During the First Year After Ostomy Creation: A Chart Review

ABSTRACT

In the first year after ostomy creation, affected persons require substantial support to manage potential complications and adjust to their new life situation. This study aimed to describe the number of visits to the stoma care nurse, the occurrence of leakage and peristomal skin complications, and the use of ostomy products to prevent these complications among persons consulting a stoma care nurse during the first year after surgery. A descriptive study was conducted using data from medical charts for 240 adults with ileostomy or colostomy. Persons with an ileostomy were more burdened by leakage and peristomal skin complications and visited the stoma care nurse more often than those with a colostomy. On average, across ostomy types, episodes of leakage and peristomal skin complications each elicited around one additional nurse visit and increased use of supporting ostomy products. Persons undergoing acute surgery, with a high ASA classification, and females experienced more episodes of leakage, peristomal skin complications and nurse visits. A patient-tailored approach based on risk factors, such as surgery type, ASA class and sex, could potentially reduce the occurrence of complications and the associated healthcare resource utilisation, including stoma care nurse visits. High variability in results further underscores the importance of personalised care.

Beyond Survival: Unveiling Psychological and Social Adaptation After Visceral Transplantation

ABSTRACT

Aim

To explore the meaning of adaptation after visceral transplantation in terms of patient experiences, symptoms, self-efficacy, transplant-specific and mental well-being.

Design

A convergent parallel mixed-methods study, consisting of interviews and generic as well as transplant-specific questionnaires. Results were integrated using meta-inference.

Methods

The study comprises a population of 17 visceral transplant recipients in Scandinavia, 12 women and 5 men with a mean age of 40.6 years (range 19–63 years) and an average follow-up of 9.4 years (range 0–25 years). Data were collected between May 2023 and January 2024 through open-ended in-depth interviews with 12 participants and analysed in accordance with phenomenological hermeneutics. Questionnaires from all 17 participants were analysed to measure transplant-specific well-being, symptoms, self-efficacy as well as anxiety and depressive symptoms.

Results

Being a visceral transplant recipient is a dynamic and life-long adaptation process that comprises two distinct yet interconnected trajectories: coherence and endurance. Coherence involves the person's ability to make sense of their situation and find meaning despite the challenges and adversity of the chronic condition. In contrast, endurance involves a person's capacity to withstand hardship and endure unpleasant or difficult experiences. Both trajectories interact dynamically, influencing and reinforcing each other. Resilience based on coherence enabled acceptance and adjustment. Conversely, uncertainty, resignation and feeling unsupported resulted in a lack of acceptance, manifested as resistance. The challenge involved in adaptation was demonstrated by 47% showing borderline elevated or elevated levels of anxiety and 18% reporting symptoms of depression. Self-efficacy varied considerably.

Conclusion

The meaning of adaptation after visceral transplantation in terms of experiences, symptoms, transplant-specific and mental well-being is balancing between coherence and endurance facilitated by acceptance and hampered by resistance. The uncertainty inherent in being a visceral transplant recipient may lead to heightened self-rated anxiety symptoms and diminished self-efficacy.

Implications for the Profession and/or Patient Care

What problem did the study adress?

This study adresses the challenges involved in being a visceral transplant recipient and adapting to life after a visceral transplantation.

What were the main findings?

Reporting Method

COREQ checklist (consolidated criteria for reporting qualitative research).

Patient or Public Contribution

No Patient or Public Contribution was organised.

A Systematic Review of Features Forecasting Patient Arrival Numbers

imageAdequate nurse staffing is crucial for quality healthcare, necessitating accurate predictions of patient arrival rates. These forecasts can be determined using supervised machine learning methods. Optimization of machine learning methods is largely about minimizing the prediction error. Existing models primarily utilize data such as historical patient visits, seasonal trends, holidays, and calendars. However, it is unclear what other features reduce the prediction error. Our systematic literature review identifies studies that use supervised machine learning to predict patient arrival numbers using nontemporal features, which are features not based on time or dates. We scrutinized 26 284 studies, eventually focusing on 27 relevant ones. These studies highlight three main feature groups: weather data, internet search and usage data, and data on (social) interaction of groups. Internet data and social interaction data appear particularly promising, with some studies reporting reduced errors by up to 33%. Although weather data are frequently used, its utility is less clear. Other potential data sources, including smartphone and social media data, remain largely unexplored. One reason for this might be potential data privacy challenges. In summary, although patient arrival prediction has become more important in recent years, there are still many questions and opportunities for future research on the features used in this area.

Family members' experiences of COVID‐19 visiting restrictions in the intensive care unit—A qualitative study

Abstract

Objective

To describe how family members of critically ill patients experienced the COVID-19 visiting restrictions in Sweden.

Background

In Sweden, the response to COVID-19 was less invasive than in many other countries. However, some visiting restrictions were introduced for intensive care units, with local variations. Although there is a growing body of literature regarding healthcare professionals' and family caregivers' perspectives on visiting restriction policies, there may be inter-country differences, which remain to be elucidated.

Design

This study has a qualitative descriptive design. Focus group interviews with 14 family members of patients treated for severe COVID-19 infection were conducted. The interviews took place via digital meetings during the months after the patients' hospital discharge. Qualitative content analysis was used to interpret the interview transcripts. Reporting of the study followed the COREQ checklist.

Results

Two categories—dealing with uncertainty and being involved at a distance—described family members' experiences of coping with visiting restrictions during the COVID-19 pandemic. These restrictions were found to reduce family members' ability to cope with the situation. Communication via telephone or video calls to maintain contact was appreciated but could not replace the importance of personal contact.

Conclusions

Family members perceived that the visiting restriction routines in place during the COVID-19 pandemic negatively influenced their ability to cope with the situation and to achieve realistic expectations of the patients' needs when they returned home.

Relevance to Clinical Practice

This study suggests that, during the COVID-19 pandemic, the visiting restrictions were experienced negatively by family members and specific family-centred care guidelines need to be developed for use during crises, including the possibility of regular family visits to the ICU.

Patient and Public Contribution

None in the conceptualisation or design of the study.

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