The Episodic Disability Questionnaire (EDQ) was developed to measure the presence, severity and episodic nature of disability experienced among persons with chronic conditions. Our aim was to assess the sensibility, utility and implementation considerations of the EDQ among older adults with complex health needs.

Cross-sectional measurement study involving quantitative and qualitative methods of data collection.

We recruited community-dwelling older adults (65 years of age or older) living with complex health needs receiving care from a primary healthcare team in Toronto, Canada.

We administered the EDQ, sensibility questionnaire (assessing face and content validity, and ease of usage, with each item scored from 0 to 7 with greater scores indicating greater sensibility) and demographic questionnaire, followed by a semi-structured interview in the home or clinical setting. Using an interview guide, we asked participants about their perspectives on utility, format and implementation of the EDQ in clinical practice. We considered the EDQ sensible if the median score on the sensibility questionnaire was ≥5/7 for ≥80% of items and if none of the items had a median score of ≤3/7. We conducted a team-based directed content analysis of the interview transcripts.

The median age of the 11 participants in this study was 83 years of age. All participants reported living with two or more chronic health conditions, with osteoarthritis (n=5) and diabetes (n=4) most frequently reported. The EDQ met the criterion for sensibility as measured by the sensibility questionnaire. Interview data from participants (n=10) indicated that the EDQ represents the health-related challenges among this sample of older adults with complex health needs, captures the episodic nature of disability and was easy to use. Utility of the EDQ included providing clinicians with a holistic understanding of health challenges older adults face, aiding in intervention planning and measuring changes in disability over time. Six of the participants also expressed uncertainty as to how the EDQ specifically could be used by clinicians in their care. Considerations for implementation included mode of administration (paper or electronic) and the importance of communicating EDQ scores with older adults based on individual preferences.

The EDQ possesses sensibility and utility for use among this sample of older adults living with complex health needs in home or clinical care settings.

Patients receiving long-term ventilation (LTV) in out-of-hospital intensive care facilities often suffer from persistent impairments of their cognition, mental health and physical health, limiting their social participation. Chronically ill patients are often unable to express their care preferences. Thus, their medical care often lacks integration of patients’ wishes and values. Telemedicine may be used to collect patient-reported outcome measures (PROMs) from these patients to align medical care with their preferences. Early integration of teleconsultation to provide rapid support for specific patient symptoms can reduce economic costs.

This is a multicentre, prospective, non-blinded, single-arm interventional trial with a pre-post design and follows the Standard Protocol Items: Recommendations for Interventional Trials statement. 10 out-of-hospital intensive care facilities in Berlin and Brandenburg, Germany, are grouped into three clusters. The study population includes adult patients (≥18 years) receiving LTV and residing in participating care facilities. During the preintervention phase, standard patient care remains unchanged. From the start of the intervention phase, enrolled patients receive telemedicine rounds in addition to standard care. These telemedicine rounds, conducted at least weekly, involve on-site healthcare professionals, patients and their relatives. Data are collected at predefined time points—study months 1,3, 9, 15 and 21—with a target of 57 participants at each time point. The study aims to evaluate whether a structured telemedicine intervention (1) increases the proportion of patients receiving record-documented PROMs in routine care and (2) reduces hospital readmissions. Secondary outcomes include the evaluation of post-intensive care syndrome, healthcare costs and the usability, applicability and perceived benefits of telemedicine. Additionally, qualitative interviews with patients, their relatives and healthcare professionals will explore individual experiences with chronic critical illness, the perceived quality of life of the patients and how team members manage moral distress in caregiving contexts. A mixed-effects logistic regression model will be used to analyse patients’ access to PROMs, while a mixed-effects Poisson regression model will be employed to evaluate hospital readmission rates. The findings may provide valuable insights into how telemedicine can improve patient-centred care for this particular patient group.

This study protocol received approval from the Ethics Committee of Charité—Universitätsmedizin Berlin, Germany (EA2/136/22). The findings will be disseminated through publication in a peer-reviewed scientific journal and presented at international conferences.

This study was registered in the ‘German Register of Clinical Studies’ (DRKS; DRKS00029326).

Patients receiving haemodialysis are at very high risk of fragility fracture, yet there are no proven treatments for fracture prevention. We will advance a pilot study on the feasibility of a large, pragmatic, randomised controlled trial (RCT) of denosumab for fragility fracture prevention in haemodialysis.

PRevEnting FracturEs in REnal Disease-1 is a pragmatic, open-label, pilot study of an RCT of a denosumab care pathway embedded in routine care haemodialysis centres.

We will recruit at least 60 participants at high risk of fracture from at least 6 haemodialysis centres in Ontario, Canada. They must be aged 40 years or older, have access to provincial drug coverage, have appropriate baseline calcium and parathyroid hormone levels and be deemed suitable for denosumab by their kidney care provider. Participants will be randomised 1:1 to denosumab (with supports to mitigate hypocalcaemia) versus usual care using block randomisation by a central statistician (computer-generated sequence). Primary outcomes include recruitment feasibility and adherence. Secondary outcomes include safety (hypocalcaemia) and participant satisfaction with our protocol and processes. Study investigators and data analysts will be blind to treatment allocation.

We will present results descriptively. The trial was approved by Clinical Trials Ontario and local research ethics boards across study sites.

Primary and secondary outcomes will be published on trial completion.

This pilot will inform the feasibility of conducting a large-scale, efficiently run, pragmatic RCT to test whether a denosumab care pathway safely reduces the risk of fragility fracture in patients receiving haemodialysis. Results have the potential to transform fracture care in real-world patients with kidney and metabolic bone disease.

NCT05096195.

Oral HIV pre-exposure prophylaxis (PrEP) is a highly effective biomedical intervention for HIV prevention, but its access and utilisation are challenging, especially in high-burden settings such as Kenya. For potential PrEP users, long delays and repeated consultations with several providers are obstacles to both PrEP uptake and continuation. The One-Stop PrEP Care project aims to promote the use of PrEP among clients in the health system and enhance client satisfaction by reducing the waiting time.

We are conducting a 1:1 cluster-randomised trial to evaluate whether One-Stop PrEP Care achieves equivalent or better PrEP outcomes compared with the standard of care model in 12 high-volume HIV clinics in Kisumu County, Kenya. In the One-Stop model, all core PrEP components, including HIV risk evaluation, HIV testing and PrEP dispensing, are provided by one provider in a single consultation room. Programme data from ≥2400 new PrEP clients will be abstracted for 12 months each to obtain primary endpoints of PrEP initiation and continuation. Adherence will be assessed via blood drug level testing. A nested cohort of up to 300 PrEP clients will be enrolled and followed every 3 months to provide in-depth data on individual HIV prevention behaviour, risk perception and how they align PrEP use with perceived risk. We will also evaluate programme costs.

Ethical approval was obtained from the University of Washington Institutional Review Board (IRB) on 8 July 2022 (IRB ID: STUDY00015873) and the Kenya Medical Research Institute Scientific and Ethics Review Unit (SERU) with a letter dated 4 May 2023 (Ref: 4697). Project findings will be shared with stakeholders, including the Ministry of Health, County health officials and participants. Results will be disseminated through manuscripts, policy briefs and health meetings.

Plans for communicating important protocol modifications include timely notifications to all study team members and training on the changes, and updates to relevant stakeholders, including the two IRBs, through protocol amendment submissions.

V. 2.0 dated 21 May 2024.

NCT03194308.

Tuberculosis (TB) remains the leading cause of infectious disease deaths, particularly among people living with HIV (PWH). Despite being preventable, TB preventive therapy (TPT) uptake is low in high-burden regions like South Africa, where new guidelines have expanded TPT eligibility and introduced shorter, more effective regimens like 3 months of weekly rifapentine and isoniazid (3HP). As differentiated service delivery models for HIV care have proven effective, there is increasing recognition that decentralising TPT delivery may improve coverage and completion. This study explores whether a community-based TPT delivery strategy can enhance uptake and completion of TPT compared with traditional clinic-based services.

We will conduct a household-randomised, non-blinded, controlled trial. Persons eligible for TPT will be recruited from the TB TRIAGE+Trial study, a community-based household TB screening study. Households containing at least one person eligible for TPT will be randomised 1:1 to either community-based TPT or standard-of-care clinic referral for TPT. At enrolment, all participants will be provided with a 2-week supply of TPT in the community. Participants randomised to the community arm will receive the entire course of TPT in a single dispense (12 weeks of 3HP or 6 months of isoniazid, if 3HP is contraindicated). Clinic-arm participants will be referred to their local clinic for the remainder of their course of TPT and will collect TPT refills on the clinic-determined schedule. Our primary outcome is the proportion of participants who complete a course of TPT. Secondary outcomes include overall adherence to TPT, predictors of adherence with TPT, participant satisfaction with the assigned TPT delivery method and adverse events.

The study and its tools were approved by the Human Sciences Research Councils Research Ethics Committee (approval number: 2/25/10/23), based in Pretoria, Gauteng, South Africa, as well as the University of Washington Institutional Review Board (Study 00018448). Study findings will be shared through the community advisory group and local stakeholder meetings, relevant international and local meetings/conferences and peer-reviewed publications.

NCT06214910. Date and version: 3.0, 30 July 2024.

Excessive sedentary behaviour (SB) is highly prevalent among children and adolescents and young adults (AYAs) treated for cancer. Although SB is associated with adverse health outcomes in adults with cancer, little is known about SB in younger cancer patients and survivors. In this scoping review, we aim to summarise current literature on (1) the association between SB and clinical outcomes and (2) results of intervention trials to reduce SB, specifically in paediatric and AYA cancer patients and survivors.

The scoping review will follow the five stages described in the Arksey and O’Malley methodology framework. We will conduct a comprehensive search in five varied electronic databases (PubMed, Embase, Web of Science, CINAHL and SportDiscus) for original articles published in peer-reviewed journals since 1 January 2000, and search reference lists of identified articles and previous review articles. All original research article types will be considered (ie, cross-sectional, cohort, interventional trials). Two reviewers will independently screen all articles based on predetermined inclusion and exclusion criteria, including (1) more than half the sample at the time of study must have been children (0–14 years old) and/or adolescent and young adults (AYAs, 15–39-year old) who were being or had been previously treated for cancer and (2) reporting of SB. Data will be extracted as a descriptive and quantitative summary of each study’s key characteristics and results. Study-specific quality assessment will be performed using established tools. Results will be presented in evidence tables with an accompanying narrative summary.

Ethics approval is not required as only publicly available data will be analysed. Results will be published in a peer-reviewed journal and may be presented at a scientific conference.

The protocol is registered in Open Science Framework (https://osf.io/ua8z9).

Understanding patient perspectives on asthma and chronic obstructive pulmonary disease (COPD) is limited, with no prior studies employing such a large-scale, proactive survey to systematically target individuals with a confirmed prescription for inhalation medication. This study aims to explore how patients with asthma or COPD manage their lives, including treatment experiences, symptoms and impacts on daily life.

A nationwide survey will be launched in January 2025, targeting adults (≥18 years) in Denmark diagnosed with asthma or COPD and prescribed or dispensed inhalation medication between 1 October 2023 and 30 September 2024. Data from the Danish Health Data Authority’s Register of Medicinal Product Statistics will identify eligible individuals. The electronic survey will be distributed via e-Boks to approximately 450 000 individuals.

The questionnaire integrates validated tools—COPD Assessment Test, Modified Medical Research Council scale, EuroQol 5-Dimension 5-Level and Asthma Control Test—alongside expert-developed questions on symptoms, diagnosis, disease control, treatment and patient experiences. Questionnaire development included 10 cognitive interviews with patients from the Outpatient Clinic at Vejle Hospital.

Descriptive statistics will be used to analyse both continuous and categorical data, with sensitivity analyses conducted as well. Data management will be handled in Research Electronic Data Capture, and statistical analyses will be performed using Stata V.18.0.

The study is registered with the Danish Data Protection Agency (24/5229) and Open Patient Data Explorative Network (OP_2094) and follows the Declaration of Helsinki. Results will be published in peer-reviewed journals, presented at national and international conferences and shared through patient associations.

This study investigated the correlation between the type of health insurance membership as a proxy for the economic status of patients and the severity of their type two diabetes mellitus (T2DM) in Indonesia.

The study conducted a secondary analysis of National Health Insurance (Jaminan Kesehatan Nasional) claim data provided by the Indonesian Social Security Agency, Badan Penyelenggara Jaminan Sosial (BPJS). We used ordered logistic regression with four severity levels for T2DM (0=outpatient, I=mild, II=moderate, III=severe) as dependent variables. The main independent variables (insurance membership categories) included subsidised insurance members (PBI), a combination of formally employed and nonsalaried informal workers (PBPU & PPU) and nonworkers (BP).

Secondary healthcare facilities in Indonesia.

The dataset included 2 989 618 claims for hospital visits of people with T2DM from 2018 to 2022.

Severity level of T2DM patients.

A higher percentage of T2DM patients who visited healthcare facilities with subsidised insurance (PBI), which represents a low-income group, have severe disease (6.9%) than patients in the PBPU & PPU (4.9%) and BP categories (5.5%). Moreover, regression analysis revealed that having PBI membership status was associated with a greater OR of having severe T2DM than nonsubsidised members. Among T2DM patients in the nonsubsidised insurance category, workers (PBPU & PPU) had an OR of 0.74 (95% CI: 0.735 to 0.745; p

These findings illustrate the lack of optimal access to health services for diabetes patients in low-income insurance membership categories and the challenges of better treatment in health facilities for low-income patients.