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Development of intersectoral medical care for patients with 'chronic critical illness: protocol for a telemedicine interventional study with a pre-post design in out-of-hospital intensive care facilities (E=MC{superscript 2})

Por: Edel · A. · Jöbges · S. · Weiss · B. · Paul · N. · Lyall · M. L. · Hoffmann · C. · Schüürhuis · S. · Piper · S. K. K. · Konietschke · F. · Berger · E. · Busse · R. · Marschall · U. · Kraufmann · B. · Witzenrath · M. · Eckardt · K.-U. · Spies · C.
Introduction

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.

Method and analysis

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.

Ethics and dissemination

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.

Trial registration number

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

Two years and counting: a prospective cohort study on the scope and severity of post-COVID symptoms across diverse patient groups in the Netherlands--insights from the CORFU study

Por: Klein · D. O. · Waardenburg · S. F. · Janssen · E. B. N. J. · Wintjens · M. S. J. N. · Imkamp · M. · Heemskerk · S. C. M. · Birnie · E. · Bonsel · G. J. · Warle · M. C. · Jacobs · L. M. C. · Hemmen · B. · Verbunt · J. · van Bussel · B. C. T. · van Santen · S. · Kietelaer · B. L. J.
Importance

Little research has been done on post-COVID symptoms at 24 months postinfection and on the association these may have on health-related quality of life (HRQOL).

Objective

We assessed the prevalence and severity of post-COVID symptoms and quantified EuroQol 5 Dimension 5 Level (EQ-5D-5L), self-perceived health question (EuroQol Visual Analogue Scale (EQ-VAS)) and health utility scores (HUS) up to 24 months follow-up.

Design

The longitudinal multiple cohort CORona Follow-Up (CORFU) study combines seven COVID-19 patient cohorts and a survey among the general public. The participants received questionnaires on several time points. Participants were stratified by: without a known SARS-CoV-2 infection (control group), proven SARS-CoV-2 infection but non-hospitalised, proven SARS-CoV-2 infection hospitalised to the ward, and proven SARS-CoV-2 infection hospitalised to the intensive care unit (ICU).

Setting

In this study, data of seven COVID-19 patient cohorts and a survey among the general public are included.

Participants

Former COVID-19 patients and controls participated in this cohort study.

Main outcomes and measures

Former COVID-19 patients and non-COVID-19 controls were sent questionnaires on symptoms associated with post-COVID condition. The CORFU questionnaire included 14 symptom questions on post-COVID condition using a five-level Likert-scale format. Furthermore, HRQOL was quantified using the EuroQol EQ-5D-5L questionnaire: EQ-VAS and the EQ-5D-5L utility score. The EQ-5D-5L questionnaire includes five domains that are scored on a five-point Likert scale: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.

Results

A total of 901 participants (and 434 controls) responded at 24 months follow-up. In all former COVID-19 patients, the presence of post-COVID condition at 24 months was observed in 62 (42.5%, 95% CI 34.3% to 50.9%) of the non-hospitalised patients, 333 (65.0%, 95% CI 60.7% to 69.2%) of the hospitalised ward patients and 156 (63.2%, 95% CI 56.8% to 69.2%) of the ICU patients, respectively (p

Conclusions

Many former COVID-19 patients experience post-COVID symptoms at 24 months follow-up, with the highest prevalence in hospitalised participants. Also, former patients reported a lower HRQOL.

Trial registration number

The CORFU study was registered at clinicaltrials.gov (registration number NCT05240742).

Establishing a framework of measurement for use in Long COVID research and practice: protocol for a scoping review involving evidence review and consultation

Por: McDuff · K. · Bhereur · A. · Kadakia · Z. · Corrales-Medina · V. F. · Gross · D. P. · Janaudis-Ferreira · T. · Lam · G. · Naik · H. · Paterson · T. S. E. · Sanchez-Ramirez · D. C. · Sasseville · M. · Sekar · A. · Vohra · S. · Bayley · M. · Birch · S. · Busse · J. W. · Cameron · J. I. · K
Introduction

Our aim is to develop a Framework of Measurement for people living with Long COVID and their caregivers for use in Long COVID research and clinical practice. Specifically, we will characterise evidence pertaining to outcome measurement and identify implementation considerations for use of outcome measures among adults and children living with Long COVID and their caregivers.

Methods and analysis

We will conduct a scoping study involving: (1) an evidence review and (2) a two-phased consultation, using methodological steps outlined by the Arksey and O’Malley Framework and Joanna Briggs Institute. We will answer the following question: What is known about outcome measures used to describe, evaluate or predict health outcomes among adults and children living with Long COVID and their caregivers? Evidence review: we will review peer review published and grey literature to identify existing outcome measures and their reported measurement properties with people living with Long COVID and their caregivers. We will search databases including MEDLINE, Embase, CINAHL, PsycINFO and Scopus for articles published since 2020. Two authors will independently review titles and abstracts, followed by full text to select articles that discuss or use outcome measures for Long COVID health outcomes, pertain to adults or children living with Long COVID and/or their caregivers and are based in research or clinical settings. We will extract data including article characteristics, terminology and definition of Long COVID, health outcomes assessed, characteristics of outcome measures, measurement properties and implementation considerations. We will collate and summarise data to establish a preliminary Framework of Measurement. Consultation phase 1: we will conduct an environmental scan involving a cross-sectional web-based questionnaire among individuals with experience using or completing outcome measures for Long COVID, to identify outcome measures not found in the evidence review and explore implementation considerations for outcome measurement in the context of Long COVID. Consultation phase 2: we will conduct focus groups to review the preliminary Framework of Measurement and to highlight implementation considerations for outcome measurement in Long COVID. We will analyse questionnaire and focus group data using descriptive and content analytical approaches. We will refine the Framework of Measurement based on the focus group consultation using community-engaged approaches with the research team.

Ethics and dissemination

Protocol approved by the University of Toronto Health Sciences Research Ethics Board (protocol #46503) for the consultation phases of the study. Outcomes will include a Framework of Measurement, to enhance measurement of health outcomes in Long COVID research and clinical practice. Knowledge translation will also occur in the form of publications and presentations.

Tick phenology, tick-host associations, and tick-borne pathogen surveillance in a recreational forest of East Texas, USA

by Jordan Salomon, Haydee Montemayor, Cassandra Durden, Dorcas Abiara, Rachel E. Busselman, Gabriel L. Hamer, Sarah A. Hamer

Management of tick-borne disease necessitates an understanding of tick phenology, tick-host associations, and pathogen dynamics. In a recreational hotspot outside of one of the largest cities in the United States, we conducted a year of monthly standardized tick drag sampling and wildlife trapping in Sam Houston National Forest, a high use recreation site near Houston in east Texas, US. By sampling 150 wildlife hosts of 18 species, including rodents, meso-mammals, deer, reptiles, and amphibians, we collected 87 blood samples, 90 ear biopsies, and 861 ticks representing four species (Amblyomma americanum, Dermacentor variabilis, Ixodes scapularis and Ixodes texanus). Drag sampling yielded 1,651 questing ticks of three species: A. americanum (921), D. variabilis (10), and I. scapularis (720). Off-host larval A. americanum abundance peaked in July, followed by peak infestations of wildlife, predominantly raccoons, in August. Off-host I. scapularis larvae abundance peaked in spring (March-May), while very few were removed from hosts and only a single I. scapularis nymph was found throughout the study via dragging in June. In contrast, both off-host and on-host adult I. scapularis occurred most frequently in the winter. Overall, tick infections included 25.3% (183/725) with Rickettsia buchneri, 15.5% (112/725) Rickettsia amblyommatis, 8.0% (58/725) Rickettsia tillamookensis, 0.8% (6/725) Rickettsia spp., and a single tick with a hard tick relapsing fever Borrelia spp.; no tick tested positive for Borrelia burgdorferi. Characterizing tick phenology, tick-host associations, and tick-borne bacteria fills important knowledge gaps for the risk of tick-borne diseases in pine-dominated forests of this region.

Intraoperative parathyroid hormone monitoring to guide surgery in renal hyperparathyroidism (PEREGRINE): a protocol for a randomised multiarm surgical pilot trial

Por: Staibano · P. · Au · M. · Pasternak · J. D. · Parpia · S. · Zhang · H. · Busse · J. W. · Nguyen · N.-T. · Monteiro · E. · Gupta · M. K. · Choi · D. L. · Lewis · T. · McKechnie · T. · Thabane · A. · Ham · J. · Young · J. E. · Bhandari · M.
Background

Secondary and tertiary renal hyperparathyroidism (RHPT) are common sequelae of chronic kidney disease and are associated with worse patient mortality and quality of life. Clinical guidelines remain lacking with regard to recommendations for using intraoperative parathyroid hormone (IOPTH) during surgery for RHPT. A prospective randomised study will help evaluate the role of IOPTH in guiding surgery for secondary and tertiary RHPT.

Methods/design

Intraoperative parathyroid hormone monitoring to guide surgery in renal hyperparathyroidism is a pragmatic, multicentre, five-arm, parallel-group, patient-blinded and outcome assessor-blinded prospective pilot trial used to evaluate the feasibility of performing a definitive trial. Eligible participants include adult patients diagnosed with secondary or tertiary hyperparathyroidism who are candidates for subtotal or total parathyroidectomy. Consenting patients will be randomly assigned, through central allocation, in a 1:1:1:1:1 fashion to undergo surgery with IOPTH monitoring (four experimental arms: postexcision IOPTH samples taken at 10, 15, 20 or 25 min) or to undergo surgery without IOPTH monitoring (control arm). The primary feasibility objective is to estimate the percentage of eligible patients that are randomised: ≥70% proceed; 50–69% modify protocol before proceeding;

Ethics and dissemination

Ethics approval was obtained from the Hamilton Integrated Research Ethics Board. Pilot trial results will be shared widely through local, national and international academic and clinical networks and will be disseminated through conference presentations and publication in peer-reviewed journals.

Trial registration number

NCT06542315, registered on 6 August 2024.

Critically ill patients undergoing interhospital transportation: a prospective multicentre cohort study in the Euregio Meuse-Rhine

Por: Florack · M. C. D. M. · Strauch · U. · Jansen · J. · Ortmanns · S. · Ramakers-van Kuijk · M. · Felzen · M. · Beckers · S. · Habers · J. · Marx · G. · van der Horst · I. C. C. · van Bussel · B. C. T. · Bergmans · D.
Objective

The principal aim of this study was to investigate differences in the characteristics and physiological parameters of critically ill patients who underwent interhospital transportation.

Design

Prospective observational cohort study.

Setting

Multicentre study within the Euregio Meuse-Rhine, including Dutch and German hospitals.

Patients

A representative sample of critically ill adult patients who underwent interhospital transport accompanied by a physician was included.

Interventions

None.

Transportation cohort description

Data on patient characteristics, transport logistics, interventions and adverse events were recorded using an online questionnaire. The cohort was divided into Dutch and German subsets and further stratified based on the transportation modality. Descriptive statistics were utilised to present the cohort characteristics.

Results

Dutch patients (89%) were mainly transported by mobile intensive care unit (MICU). For the present investigation, in Germany, the Intensivtransportwagen was included in this MICU category, whereas German patients (48%) were mainly transported by intensive care ambulance (ICA). An intensivist accompanied most transports in the Netherlands, whereas various specialists transported patients in Germany. Interventions were primarily performed in the MICU for Dutch patients and in the ICA for German patients. Adverse events were reported in 5% of the cases.

Conclusions

These comprehensive data provide insights into the transportation differences of critically ill patients. This serves as a foundation for future investigations concerning the quality and efficacy of interhospital transportation.

Trial registration number

This study was registered in the Dutch National Trial Registration (NTR4937).

Effectiveness of a community-based rehabilitation programme following hip fracture: results from the Fracture in the Elderly Multidisciplinary Rehabilitation phase III (FEMuR III) randomised controlled trial

Por: Williams · N. · Busse · M. · Cooper · R. · Dodd · S. · Dorkenoo · S. · Doungsong · K. · Edwards · R. T. · Green · J. · Hardwick · B. · Lemmey · A. · Logan · P. · Morrison · V. · Ralph · P. · Sackley · C. · Smith · B. E. · Smith · T. · Spencer · L. H.
Objective

To determine whether an enhanced community rehabilitation intervention (the Fracture in the Elderly Multidisciplinary Rehabilitation (FEMuR) intervention) was more effective than usual National Health Service care, following surgical repair of hip fracture, in terms of the recovery of activities of daily living (ADLs).

Design

Definitive, pragmatic, multisite, parallel-group, two-armed, superiority randomised controlled trial with 1:1 allocation ratio.

Setting

Participant recruitment in 13 hospitals across England and Wales, with the FEMuR intervention delivered in the community.

Participants

Patients aged over 60 years, with mental capacity, recovering from surgical treatment for hip fracture and living in their own home prior to fracture.

Interventions

Usual rehabilitation care (control) was compared with usual rehabilitation care plus the FEMuR intervention, which comprised a patient-held workbook and goal-setting diary to improve self-efficacy, and six additional therapy sessions delivered in-person in the community, or remotely during COVID-19 restrictions (intervention), to increase the practice of exercise and ADL.

Primary and secondary outcome measures

Primary outcome was the Nottingham Extended Activities of Daily Living (NEADL) scale at 12 months. Secondary outcomes included: Hospital Anxiety and Depression Scale, Falls Self-Efficacy-International scale, hip pain intensity, fear of falling, grip strength and Short Physical Performance Battery. Outcomes were collected by research assistants in participants’ homes, whenever possible, but had to be collected remotely during COVID-19 restrictions.

Results

In total, 205 participants were randomised (n=104 experimental; n=101 control). Trial processes were adversely affected by the COVID-19 pandemic. There were 20 deaths, 34 withdrawals and three lost to follow-up. At 52 weeks, there was no significant difference in NEADL score between the FEMuR intervention and control groups. Joint modelling analysis testing for difference in longitudinal outcome adjusted for missing values also found no significant difference with a mean difference of 0.1 (95% CI –1.1, 1.3). There were no significant between-group differences in secondary outcomes. Sensitivity analyses, examining the impact of COVID-19 restrictions, produced similar results. A median of 4.5 extra rehabilitation sessions were delivered to the FEMuR intervention group, with a median of two sessions delivered in-person. Instrumental variable regression did not find any effect of the amount of rehabilitation on the main outcome. There were 53 unrelated serious adverse events (SAEs) including 11 deaths in the control group: 41 SAEs including nine deaths in the FEMuR intervention group.

Conclusions

The FEMuR intervention was not more effective than usual rehabilitation care. The trial was severely impacted by COVID-19. Possible reasons for lack of effect included limited intervention fidelity (fewer sessions than planned and remote delivery), lack of usual levels of support from health professionals and families, and change in recovery beliefs and behaviours during the pandemic.

Trial registration number

ISRCTN28376407.

Creativity research in medicine and nursing: A scoping review

by Alex Thabane, Sarah Saleh, Sushmitha Pallapothu, Tyler McKechnie, Phillip Staibano, Jason W. Busse, Goran Calic, Ranil Sonnadara, Sameer Parpia, Mohit Bhandari

Background

Creativity fuels societal progress and innovation, particularly in the field of medicine. The scientific study of creativity in medicine is critical to understanding how creativity contributes to medical practice, processes, and outcomes. An appraisal of the current scientific literature on the topic, and its gaps, will expand our understanding of how creativity and medicine interact, and guide future research.

Objectives

We aimed to assess the quantity, trends, distribution, and methodological features of the peer-reviewed on creativity in medicine.

Methods

We searched the MEDLINE, EMBASE, and PsycINFO databases for peer-reviewed primary research publications on creativity in medicine. Screening, full-text review, and data extraction were performed independently and in duplicate by pairs of reviewers, with discrepancies resolved by a third reviewer. We performed descriptive analyses, graphically displaying the data using charts and maps where appropriate.

Results

Eighty-one studies were eligible for review, enrolling a total of 18,221 physicians, nurses and midwifes across all studies. Most research on creativity in medicine was published in the last decade, predominately in the field of nursing (75%). Researchers from Taiwan (22%) and the United States (21%) produced the most eligible publications, and the majority research was cross-sectional in nature (54%). There was substantial variability in the definitions of creativity adopted, and most studies failed to specify a definition of creativity. Forty-five different measurement tools were used to assess creativity, the most popular being divergent thinking tests such as the Torrance Test of Creative Thinking (24%) and Guilford Creativity Tests (16%).

Conclusions

Peer-reviewed scientific research on creativity in medicine, mostly conducted in the nursing profession, is sparse and performed on variable methodological grounds. Further scientific research on the topic, as well as the development of medicine-specific definitions and measurement tools, is required to uncover the utility of creativity in the medical domain.

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