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To develop survey items for a national patient registry on Long COVID using a modified Delphi process.
This study was based on a modified Delphi process involving three rounds of anonymous, online surveys to develop consensus on and prioritise survey elements to be included in a minimum dataset for use in a national patient registry in Canada. Initial Long COVID items were identified through an environmental scan of the literature.
This study focused on healthcare systems in Canada and was conducted online.
A panel of 52 experts (patients, caregivers, clinicians and researchers) participated in all three rounds of the online survey. These participants were recruited through the Long COVID Web network and word of mouth.
In total, 243 survey elements related to care, quality of life and symptoms were included in round 1 of the survey. 200 reached consensus and moved to round 2 with two additional elements being developed based on open-ended responses. In round 2, participants ranked these survey elements and 34 advanced. In round 3, 33 survey elements met the threshold of consensus with one added a priori. The 33 survey elements were then used to develop a Long COVID minimum dataset, which consists of 48 items.
The findings affirm broad consensus for collecting data related to fatigue, post-exertional malaise, cardiovascular issues, respiratory problems and cognitive issues. This highlighted the desire for quality-of-life indicators and information related to care utilisation, quality and access.
The only supportive therapy for patients with severe acute kidney injury (AKI), a common complication among the critically ill, is dialysis. Based on the literature and current guidelines, continuous renal replacement therapy (CRRT) with a total effluent dose of 20–25 mL/kg/hour and adjustments to ensure such dose is delivered despite down time (eg, due to surgical procedures) is recommended. However, experimental and clinical studies suggest that azotaemia, which can be induced by lowering the effluent dose, may accelerate renal recovery. This clinical study investigates whether a lower effluent dose (10–15 mL/kg/hour) for a maximum of 7 days or until successful (>24 hours) liberation of CRRT in critically ill patients with a dialysis-dependent AKI accelerates renal recovery and reduces time on CRRT compared with guideline-directed standard dose (25–30 mL/kg/hour).
The Ketzerei trial is an international, multicentre randomised, controlled trial, designed to investigate if a lower effluent dose (10–15 mL/kg/hour) accelerates renal recovery and reduces the time on CRRT compared with the guideline directed standard effluent dose (25–30 mL/kg/hour). The study aims to enrol 150 critically ill patients with a dialysis-dependent AKI. Eligible patients will be randomised to receive either a standard effluent dose (control group, 25–30 mL/kg/hour) or lower effluent dose (interventional group, 10–15 mL/kg/hour). The primary endpoint is the number of days free from CRRT and alive (from randomisation through day 28). Key secondary endpoints include the number of (serious) adverse events due to potential uremia, the duration of RRT and intensive care unit survival.
The Ketzerei trial has been approved by the Ethics Committee of the Chamber of Physicians Westfalen-Lippe (2023–343 f-s), the University of Muenster and subsequently by the corresponding Ethics Committee of the participating sites. Results will be disseminated widely and published in peer-reviewed journals, presented at conferences and will guide patient care and further research.
clinicaltrials.gov (NCT06021288).
For patients with perihilar cholangiocarcinoma (pCCA), surgical resection remains the sole treatment modality that can potentially result in cure. Unfortunately, the majority of patients present with unresectable tumours or are excluded from surgical treatment due to complications like cholangitis affecting their performance status. In the Netherlands, recommended first-line treatment for patients with unresectable pCCA is palliative chemotherapy with gemcitabine and cisplatin. This regimen yields an estimated median overall survival (OS) of 11.7–15.2 months, highlighting the urgent need for novel treatment options. The STRONG I trial, a phase I study in patients with unresectable pCCA, was completed in 2020. Its aim was to assess the feasibility and toxicity profile of adding stereotactic body radiation therapy (SBRT) to chemotherapy. SBRT, delivered in 15 fractions of 4.0 Gray (Gy), was considered to be feasible and safe, with no dose-limiting toxicity being observed. The 1-year local tumour control rate was 80% and the 1-year OS rate 100%, with maintenance of quality of life (QoL). These results encouraged us to initiate the STRONG II trial, aiming to investigate the efficacy of adding SBRT to chemotherapy in a larger patient cohort.
STRONG II is a single-arm, multicentre phase II study. Patients with non-metastatic unresectable pCCA (T1-4, N0-2) are eligible. A total of 30 patients will be enrolled in six academic centres in the Netherlands and two in Belgium. SBRT will be delivered in 15 fractions of 4.0–4.5 Gy. The primary endpoint is local tumour control, defined by Response Evaluation Criteria in Solid Tumours (RECIST) V.1.1. Secondary endpoints include toxicity, biliary stent-related events, progression-free survival, OS and QoL using the EuroQoL five-dimensional, five-level (EQ-5D-5L) questionnaire, European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) and the EORTC Biliary Module (QLQ-BIL21). In addition, we will explore the predictive value of the peripheral immunological status (immune-related proteins and serum functional immunological status assay) and its dynamics in determining survival outcomes. For this explorative translational study, two blood samples will be collected, one before the start of chemotherapy and another after completing chemotherapy.
Approval of the study was obtained on 5 June 2024 by the Medical Ethics Review Committee of Erasmus Medical Center Rotterdam, the Netherlands (ID: NL86210.078.24). The anticipated time frame for patient enrolment is July 2024 to December 2027. The main study findings will be published in peer-reviewed medical journals, and presented at national and international conferences.
NCT06493734 (ClinicalTrials.gov).
During the COVID-19 pandemic, a substantial decrease was observed in hospital admissions and in-hospital procedures for patients with acute cardiovascular diseases (CVDs). The extent to which measures to prevent COVID-19 transmission, for example, lockdowns, affected the outpatient care of patients at higher cardiovascular risk remains unclear. We aimed to compare outpatient department (OPD) attendance, cardiovascular risk management (CVRM) and cardiovascular health (CVH) of patients at higher cardiovascular risk referred to an OPD of a tertiary care centre between preCOVID-19, during and postCOVID-19 periods.
We included all adult patients at higher cardiovascular risk referred to the cardiology, vascular medicine, diabetology, geriatrics, nephrology or multidisciplinary vascular surgery OPDs of the University Medical Centre Utrecht, the Netherlands, between March 2019 and December 2022, in a prospective cohort study.
We assessed trends in the number of first and follow-up appointments and in the completeness of extractable CVRM indicators from the electronic health record (EHR) as a proxy for CVRM guideline adherence. CVH was determined using the Life’s Essential 8 metric (score 0–100, the higher score, the better). We investigated whether CVH differed between COVID-19 periods compared with the reference period (ie, 2019) and stratified by OPDs, using multivariable linear regression, adjusted for age, gender, CVD history and whether the patient had a previous appointment before the reference period.
Among 15 143 patients, we observed a 33% reduction in the weekly number of first appointments during the COVID-19 pandemic, with the largest reductions in the cardiology and nephrology OPDs, with no differences between women and men. Follow-up appointments conducted remotely, compared with before the COVID-19 pandemic, increased significantly for all OPDs. CVRM indicators were up to 11% less extractable during the first lockdown yet returned to prepandemic levels directly after the first lockdown period. The CVH score of patients visiting the nephrology, vascular medicine and geriatrics OPDs during the first lockdown was 11.23 (95% CI 2.74 to 19.72), 5.68 (95% CI 0.82 to 10.54) and 5.66 (95% CI 0.01 to 11.31) points higher, respectively, compared with the prepandemic period. In between the second and third lockdowns, the CVH score was comparable to the preCOVID reference period, yet for the cardiology OPD it was significantly higher (5.54, 95% CI 2.04 to 9.05).
During the COVID-19 pandemic, weekly numbers of first appointments to OPDs decreased, and a population with a higher CVH score (ie, better CVH) visited certain OPDs, especially during the first lockdown period. These suggest that patients with poorer CVH more often avoided or were unable to visit OPDs, which might have resulted in missed opportunities to control cardiovascular risk factors and potentially may have led to preventable disease outcomes. For future epidemics and pandemics, it seems vital to develop a strategy that includes an emphasis on seeking healthcare when needed, with specific attention to patients at higher CVD risk.
To gain insight into healthcare professionals' perceptions and needs regarding hospital-to-home transitions.
Qualitative phenomenological study.
Hospital and primary care professionals participated in focus groups and interviews. Participants were recruited from a Dutch University hospital and from our networks between May and September 2023. Data were analysed using thematic analysis.
We conducted seven focus groups and twelve interviews. Three themes emerged: “Collaboration and information exchange between professionals”, “Coordination and continuity of care”, and “Interaction between professionals, patients, and families”.
This study suggests that professionals would benefit from clear guidelines and arrangements for communication with colleagues to support care coordination and continuity. Collaboration and information sharing are essential for providing integrated, patient-centred care. Additionally, involving patients and families in decision-making regarding hospital-to-home transitions, in a way that considers their needs, is important for effective care.
This study highlights the importance of clear communication and collaboration between professionals to ensure continuity of care. It emphasises the need for integrated care, where patients and families are actively involved without being overwhelmed.
Transitions from hospital-to-home are often hindered by fragmented, non-individualised care. Improved collaboration, clear coordination, and patient-family involvement can address this. This research can positively impact professionals across different settings, policymakers, and advocacy groups aiming to improve integrated patient-centred care.
The interview guide was developed with professionals who reviewed it and provided feedback. Professionals provided us with their lived experiences by participating in interviews and focus groups.
This study adhered to the COREQ guidelines.
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The aim of this research study is to collaboratively generate insights in the current institutional long-term care environment for activity and mobility of older adults, and of solutions that could be used to increase the activity and improve the mobility of the older adults.
This research constitutes a qualitative study with a critical approach.
Data were collected using photo-elicitation in four long-term care units in Finland during the spring of 2022. Older adults participated in individual data collection sessions which combined photographing and discussion. Staff members individually took photographs and later participated in a group discussion based on the photographs. Reflexive thematic analysis was used to analyse all data together.
Ten older adults and 12 staff members participated in the research study. Four themes were identified: (1) facilities should be designed and equipped for their users, (2) moving in the institutional environment, (3) passivity as a norm, and (4) nurses should act differently and have the resources to do so.
To increase the activity and improve the mobility of older adults, improvements are needed in terms of the design of facilities, opportunities for freedom of movement, outdoor activity, daily life activities, exercise, nurses' role in activating older adults and resources.
Increased attention to the support of activity and mobility could benefit older adults in institutional long-term care. Physical activity promotion should be incorporated as an integral part of nursing practice.
Directors of units were consulted when planning the study. Older adults and nurses contributed to the data collection and interpretation of data.
What problem did the study address? ○Older adults have recurrently been reported as living inactive lives in institutional long-term care. ○There is evidence of the relationship between the environment and the activity and mobility of older adults, but there seems to be a research-practice gap in terms of implementing activity- and mobility-promoting environments. ○Older adults and staff members are important in developing practice and change-oriented knowledge that can be used to increase the activity and improve the mobility of older adults in institutional long-term care.
What were the main findings? ○Various environmental improvements are recommended to increase the activity and improve the mobility of older adults in institutional long-term care settings. ○Improvements for the design of facilities, opportunities for freedom of movement, outdoor activity, daily life activities, exercise, nurses' role in activating older adults and resources for activity support would benefit older adults' activity and mobility.
Where and on whom will the research have an impact? ○Increasing the activity of older adults requires better activity promotion and mobility support by nurses in institutional care. Sufficient education and resources should be organized for activity promotion, in addition to a care and organizational culture that values activity. ○Environmental aspects to promote activity and mobility need to be considered already at the planning, building and renovating phases of facilities. ○Policymakers and care organizers should consider evidence of the harms and benefits of different institutional living environments when making decisions on organizing care.
The study is reported using the Consolidated Criteria for Reporting Qualitative Research (COREQ).
FreshRSS 