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Patient perspectives on the usability and content validity of the assessment of burden of chronic conditions tool for post-COVID in the Netherlands: a qualitative study

Background

Post-COVID syndrome manifests with a diverse array of symptoms for which no standard care plan currently exists. Many questions were raised by patients, which underscored the need for a validated patient-reported outcome measure (PROM). Therefore, a post-COVID module was developed to be included in the Assessment of Burden of Chronic Conditions (ABCC-) tool. The ABCC-tool evaluates and visualises the perceived physical, emotional and social burden of one or multiple chronic disease(s) using a balloon diagram and aims to facilitate person-centred care and structured discussions between patients and healthcare professionals. This study explores the patients’ perspective on the content of the ABCC-tool for post-COVID and the tool’s usability in a home-based setting.

Methods

All patients who completed the ABCC-tool for post-COVID were invited for an online semi-structured interview. We selected post-COVID patients who had used the tool in the past three months. Interviews were audio recorded and analysed using a thematic approach with Atlas.ti version 23.

Results

Nineteen post-COVID patients (10 males, mean age 56) were interviewed between May and August 2024. The tool was regarded as user-friendly, and patients indicated they would use the tool again in the future. Patients valued the tool’s broad range of topics, some of which are often overlooked in standard healthcare consultations. The tool was comprehensible and relevant according to all patients. The balloon diagram was easy to understand, but a legend explaining the colours of the balloons was preferred. Other suggestions for improvement included adding open-text fields and periodic reminders to increase usability and adding long-term data.

Conclusions

The ABCC-tool is a promising instrument for post-COVID patients, offering a structured way to monitor and communicate experienced burden in addition to standard healthcare consultations. Refinements addressing usability and comprehensiveness are recommended to facilitate its integration into clinical practices.

Protocol for a modified Delphi study of ethical oversight of data science health research (DSHR)

Introduction

The use of data science for health research produces complex ethical, legal and social challenges that traditional ethical oversight mechanisms struggle to address. In Nigeria, the current ethical guidelines were not designed for these challenges which include pervasive data environments, consent for secondary data use, algorithmic decision-making and bias, privacy risks, involvement of commercial entities, data colonisation, inequitable benefit-sharing and commercial data holdings. To address these gaps, we developed a draft guideline incorporating principles like trust, veracity, global justice and alternative ethical approval mechanisms. Here, we describe the protocol for a study aimed at validating the guideline through stakeholder consensus on the content, feasibility and acceptability of this subcode for national implementation.

Methods and analysis

We describe the use of a modified e-Delphi approach to iteratively synthesize expert opinions about ethical oversight for data science health research (DSHR) led by a multidisciplinary working group from the Bridging Gaps in the ELSI of Data Science Health Research in Nigeria (BridgELSI) team. We will invite 65 experts, including health researchers, ethics committee members, data scientists, health policymakers, funders and key opinion leaders in Nigeria to participate. Participants will rate 13 core principles, including global justice, algorithmic bias, data governance and related governance provisions on importance, desirability for inclusion in national guidelines, feasibility and confidence in implementation, using 5-point Likert scales, with optional free-text comments. We will summarise responses using descriptive statistics, assess consensus and polarity using pre-specified thresholds for the mean and IQR, and iteratively refine statements between rounds using qualitative content analysis of comments.

Ethics and dissemination

Ethical approval was obtained from the Nigerian National Health Research Ethics Committee and the University of Maryland IRB, and participants will provide informed consent. Results will be shared with the expert panel and national regulators and disseminated via publications and conferences.

Telerehabilitation for people with Parkinsons disease: protocol of a randomised clinical trial of mixed methods

Por: Taveira · R. S. · Vasconcellos · L. S. d. · Bezerra · C. F. · Aires · D. N. · Dias de Oliveira · A. K. · da Silva · K. d. O. C. · Melo · L. P. d. · Ribeiro · T. S.
Introduction

Telerehabilitation (TR) programmes are increasingly recognised for their feasibility and potential benefits, such as eliminating travel time, reducing costs and providing a more comfortable rehabilitation experience at home. However, the comparative efficacy of remote physiotherapy compared with traditional in-person sessions for individuals with Parkinson’s disease (PD) remains uncertain. This study aims to evaluate the effects of TR compared with in-person physiotherapy in individuals with PD, focusing on both motor and non-motor outcomes.

Methods and analysis

This is a randomised, single-blind clinical trial with a mixed-methods approach. A total of 22 individuals diagnosed with PD will be randomly assigned to one of two groups. The experimental group will receive TR, consisting of remote physiotherapy sessions conducted once a week for 1 hour over a 4-month period. The control group will receive the same interventions in person. Interventions will include global muscle strengthening exercises, balance training, gait and motor coordination exercises, and cognitive training. The primary outcome will be motor function, measured using part III of the Movement Disorder Society–Unified Parkinson’s Disease Rating Scale. Secondary outcomes will include cognition (Montreal Cognitive Assessment), gait (Functional Gait Assessment), mobility (Timed Up and Go Test) and quality of life (Parkinson’s Disease Questionnaire). Data will be analysed using repeated measures analysis of variance to compare outcomes between groups across four assessment points (baseline, midpoint, postintervention and 2 months follow-up). Additionally, a qualitative phase will explore participants’ perceptions and experiences regarding TR and in-person interventions, with assessments carried out 2 months after the completion of the 24-week interventions, through semistructured interviews that will be analysed using Bardin’s Content Analysis technique.

Ethics and dissemination

This protocol was approved by the Research Ethics Committee of the Federal University of Rio Grande do Norte (approval number: 5.553.701). All participants will provide written informed consent before inclusion. Results will be disseminated through peer-reviewed publications, scientific conferences and communication with participants and healthcare professionals.

Trial registration number

RBR-6h5knrj.

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.

How can post-COVID care be improved using patient experiences with received care and perceived health? A qualitative study of focus groups with 30 patients having post-COVID in the Netherlands

Por: Gruiskens · J. · Gidding-Slok · A. H. · van Meulenbroek · T. · Huijnen · I. · Muris · J. W. M. · Verbunt · J. · van Schayck · O. C. · Burgers · J. S.
Objectives

To provide bottom-up guidance on improving post-COVID care using patients’ experiences with received care and their perceived health

Design

Qualitative study design using focus group interviews

Participants

30 patients with post-COVID condition recruited through purposive sampling based on patient complexity and diversity

Results

Three dimensions for potential improvements of post-COVID care were identified: (1) building, supporting and maintaining patient resilience, (2) redesigning healthcare pathways to meet patient needs and (3) embedding post-COVID care in health systems and organisations. A conceptual framework that could guide improvements in post-COVID care was developed.

Conclusion

This study revealed several opportunities for improving and implementing post-COVID care following a person-centred approach in multidisciplinary integrated care pathways with an integrative vision of health.

Antepartum Anxiety, Dyadic Coping, and Stress Among Chinese Pregnant Couples: The Actor‐Partner Interdependence Mediation Model

ABSTRACT

Introduction

Pregnancy can cause stress for couples, potentially leading to anxiety. However, most studies on antepartum anxiety focus on expectant mothers, ignoring the expectant fathers and the stress transmission between couples. We aim to examine the mediation of dyadic coping between antepartum anxiety and stress in expectant mothers and fathers.

Design

We implemented a cross-sectional study in Guangzhou, China, from October 2023 to January 2024.

Methods

Three-hundred and twenty-nine Chinese pregnant couples completed the Perceived Stress Scale, the Dyadic Coping Inventory, and the State–Trait Anxiety Inventory. The actor-partner interdependence mediation model was used for data analysis.

Results

Expectant mothers experienced antepartum anxiety symptoms at a rate of 42.6%, while the rate for expectant fathers was 32.5%. Regarding the actor effects, stress was positively associated with antepartum anxiety in expectant mothers (β = 0.66, 95% confidence interval CI [0.56, 0.74]) and fathers (β = 0.58, 95% CI [0.42, 0.70]), with dyadic coping acting as a mediator (expectant mothers: β = 0.08, 95% CI [0.03, 0.14]; fathers: β = 0.11, 95% CI [0.04, 0.19]). Regarding the partner effects, maternal dyadic coping was positively associated with paternal stress (β = 0.10, 95% CI [0.01, 0.19]).

Conclusion

The study highlights the interplay of stress, dyadic coping, and antepartum anxiety in expectant mothers and fathers, emphasizing the need to assess their antepartum anxiety and implement couple-centered interventions to enhance their psychological well-being during the first trimester of pregnancy.

Clinical Relevance

This study highlights the importance of assessing antepartum anxiety in both expectant mothers and fathers, emphasizing the mediation of dyadic coping in reducing stress and anxiety. The findings support the integration of couple-centered mental health interventions into routine antepartum care to enhance psychological well-being during pregnancy.

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