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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).

Geographic environments, daily activities and stress in Luxembourg (the FragMent study): a protocol combining map-based questionnaires, geographically explicit ecological momentary assessment and vocal biomarkers of stress

Por: Perchoux · C. · Topalian · N. · Klein · S. · Chaix · B. · Tharrey · M. · Röcke · C. · Gerber · P. · Klein · O. · Missling · A. · Omrani · H. · Helbich · M. · Van Dyck · D. · Kestens · Y. · Dijst · M. · Fagherazzi · G.
Introduction

Stress is nearly ubiquitous in everyday life; however, it imposes a tremendous burden worldwide by acting as a risk factor for most physical and mental diseases. The effects of geographic environments on stress are supported by multiple theories acknowledging that natural environments act as a stress buffer and provide deeper and quicker restorative effects than most urban settings. However, little is known about how the temporalities of exposure to complex urban environments (duration, frequency and sequences of exposures) experienced in various locations – as shaped by people’s daily activities – affect daily and chronic stress levels. The potential modifying effect of activity patterns (ie, time, place, activity type and social company) on the environment–stress relationship also remains poorly understood. Moreover, most observational studies relied quasi-exclusively on self-reported stress measurements, which may not accurately reflect the individual physiological embodiment of stress. The FragMent study aims to assess the extent to which the spatial and temporal characteristics of exposures to environments in daily life, along with individuals’ activity patterns, influence physiological and psychological stress.

Methods and analysis

A sample of 2000 adults aged 18–65 and residing in the country of Luxembourg completed a traditional and a map-based questionnaire to collect data on their perceived built, natural and social environments, regular mobility, activity patterns and chronic stress at baseline. A subsample of 200 participants engaged in a 15-day geographically explicit ecological momentary assessment (GEMA) survey, combining a smartphone-enabled global positioning system (GPS) tracking and the repeated daily assessment of the participants’ momentary stress, activities and environmental perceptions. Participants further complete multiple daily vocal tasks to collect data on vocal biomarkers of stress. Analytical methods will include machine learning models for stress prediction from vocal features, the use of geographic information systems (GIS) to quantify dynamic environmental exposures in space and time, and statistical models to disentangle the environment–stress relationships.

Ethics and dissemination

Ethical approval (LISER REC/2021/024.FRAGMENT/4-5-9-10) was granted by the Research Ethics Committee of the Luxembourg Institute of Socio-Economic Research (LISER), Luxembourg. Results will be disseminated via conferences, peer-review journal papers and comic strips. All project outcomes will be made available at https://www.fragmentproject.eu/.

Nurse‐sensitive quality and benchmarking in hospitals striving for Magnet® or Pathway® designation: A qualitative study

Abstract

Aim

To examine if and how selected German hospitals use nurse-sensitive clinical indicators and perspectives on national/international benchmarking.

Design

Qualitative study.

Methods

In 2020, 18 expert interviews were conducted with key informants from five purposively selected hospitals, being the first in Germany implementing Magnet® or Pathway®. Interviews were analyzed using content analysis with deductive-inductive coding. The study followed the COREQ guideline.

Results

Three major themes emerged: first, limited pre-existence of and necessity for nurse-sensitive data. Although most interviewees reported data collection for hospital-acquired pressure ulcers and falls with injuries, implementation varied and interviewees highlighted the necessity to develop additional nurse-sensitive indicators for the German context. Second, the theme creating an enabling data environment comprised building clinicians' acceptance, establishing a data culture, and reducing workload by using electronic health records. Third, challenges and opportunities in establishing benchmarking were identified but most interviewees called for a national or European benchmarking system.

Conclusion

The need for further development of nurse-sensitive clinical indicators and its implementation in practice was highlighted. Several actions were suggested at hospital level to establish an enabling data environment in clinical care, including a nationwide or European benchmarking system.

Implications for the Profession and Patient Care

Involving nurses in data collection, comparison and benchmarking of nurse-sensitive indicators and their use in practice can improve quality of patient care.

Impact

Nurse-sensitive indicators were rarely collected, and a need for action was identified. The study results show research needs on nurse-sensitive indicators for Germany and Europe. Measures were identified to create an enabling data environment in hospitals. An initiative was started in Germany to establish a nurse-sensitive benchmarking capacity.

Patient or Public Contribution

Clinical practitioners and nurse/clinical managers were interviewed.

Investigation of the combined effects of cannabidiol plus naltrexone on alcohol craving in alcohol dependence: study protocol of a phase II randomised, double-blind, placebo-controlled, parallel-group trial - ICONICplus Trial

Por: Vetter · S. · Weinberg · J. · Thomas · B. C. · Kirchner · M. · Thalmann · P. · Klose · C. · Pfisterer · M. · Kölsch · T. · Oesterle · S. · Vollstaedt-Klein · S. · Koopmann · A. · Lenz · B. · Kiefer · F. · Link · T. · Bach · P.
Introduction

Alcohol dependence (AD) is highly prevalent and has severe consequences on health and quality of life. However, the efficacy of approved pharmacotherapies such as naltrexone (NTX) remains limited, highlighting the need for novel pharmacotherapeutic approaches. Cannabidiol (CBD) is a promising candidate, which has shown potential to reduce craving and alcohol use by modulating brain circuits involved in craving and addiction. Preclinical studies suggest that CBD may enhance NTX’s therapeutic effects.

Methods and analysis

This is a three-armed, randomised, double-blind, placebo-controlled parallel group, multicentre phase II clinical trial. A total of 150 patients with AD will be randomised (1:1:1) to receive either 800 mg or 1200 mg CBD plus 50 mg oral NTX or placebo plus 50 mg oral NTX for 14 days. Alcohol craving will be assessed using the Obsessive Compulsive Drinking Scale (OCDS-G) where the primary endpoint is the change from baseline to the end of treatment. Secondary outcomes include craving during the entire study, quality of life, depressive symptoms, anxiety, patient-reported outcomes, neural brain activation, CBD plasma levels, time to relapse, alcohol use and treatment safety. For the comparison of each experimental group to the control group, a strata-adjusted (centre and baseline OCDS-G) van Elteren test is applied with adjustment for multiple testing by Bonferroni-Holm.

Ethics and dissemination

The trial has been approved by the Ethics Committee and the competent authority (ID: B_03510). All participants will provide written informed consent. An independent Data and Safety Monitoring Board will monitor safety. This trial complies with national and international regulations.

Trial registration number

NCT06845124; EU Trial Number: 2024-518164-12-00.

Prehospital antibiotics and intravenous fluids for patients with sepsis: protocol for a 2x2 factorial randomised controlled trial

Por: Scales · D. C. · Rogowsky · A. · Burry · L. · Christenson · J. · Daneman · N. · Drennan · I. R. · Hillier · M. · Jenneson · S. · Klein · G. · Mazzulli · T. · Moran · P. · Morris · A. M. · Morrison · L. J. · Pinto · R. · Rubenfeld · G. D. · Seymour · C. W. · Stenstrom · R. · Verbeek · P. R
Introduction

Prompt recognition and treatment of patients with sepsis improve survival. Patients transported to hospital with sepsis often do not receive treatment until they are assessed in emergency departments. Initiation of treatments by paramedics at the point of first contact may improve outcomes for these patients.

Methods and analysis

The study design involves two randomised controlled trials (RCTs) conducted using a 2x2 factorial design comparing use of (1) early intramuscular ceftriaxone versus placebo and (2) an early liberal intravenous fluid strategy (up to 2 L normal saline) versus usual care resuscitation guided by paramedic medical directives. Patients who are ≥18 years of age will be eligible for inclusion if they have sepsis, defined as (1) paramedic suspicion of infection, (2) fever (temperature ≥38.0°C measured by paramedic or history of fever during the previous 24 hours), and (3) hypotension: SBP 250 mL) within 24 hours of hospital arrival; total amount of crystalloid infused during transport and first 24 hours of hospitalisation; and proportion of enrolled patients not suspected to have sepsis or infection by emergency department physicians. Safety outcomes include the proportion of patients with pulmonary oedema during transport to hospital and on initial chest X-ray and the proportion of patients with anaphylaxis or suspected allergic reactions to study medication.

Ethics and dissemination

This study has been approved through Clinical Trials Ontario’s streamlined ethics review process (board of record, Sunnybrook Health Sciences Centre). It will be conducted in accordance with the Declaration of Helsinki, Good Clinical Practice guidelines and regulatory requirements. The final results will be disseminated to participating paramedic services through educational materials, presentations and interactive training. We anticipate our trial will achieve wide dissemination through publication in a peer-reviewed medical journal and presentation at international conferences targeting the fields of prehospital and emergency medicine, resuscitation and critical care.

Trial registration number

NCT03068741.

Impact of race, sex and age on the probability of pancreatic cancer among patients with newly diagnosed diabetes in a claims-based cohort

Por: Afghani · E. · Lau · B. · Becker · L. K. · Goggins · M. · Klein · A. P.
Objective

Pancreatic cancer diagnoses are frequently preceded by a new diabetes diagnosis. Screening individuals newly diagnosed with diabetes could enable the earlier detection of pancreatic cancer. We sought to estimate the risk of pancreatic cancer by age, sex, race and time since diabetes diagnosis.

Design

Claims-based cohort study.

Setting

Johns Hopkins Medicine conducted this deidentified claims-based cohort study using the Optum Labs Data Warehouse.

Participants

Insurance enrollees from 1/2008–9/2018 were identified as non-diabetic or newly diagnosed diabetic. Our risk set included 4 732 313 individuals (424 129 newly diabetic) in 5 844 934 enrolment periods.

Primary outcome measures

Time to pancreatic cancer. Diabetes and cancer were defined using International Classification of Diseases (ICD)-9/10 codes.

Results

Individuals with newly diagnosed diabetes were at an increased HR of pancreatic cancer, but this effect waned over time. The HR of pancreatic cancer following a diabetes diagnosis was higher in younger individuals and varied by race (lower HR in non-White individuals) (p

Conclusions

Consideration of the age–race–sex specific probability of pancreatic cancer and time since diabetes diagnosis is necessary when evaluating the risk of pancreatic cancer following a diabetes diagnosis.

Characterizing suicidal thoughts and behaviours in individuals presenting to a psychiatric emergency department: a protocol for a multimethod approach for suicide prevention research

Por: Baharikhoob · P. · Maslej · M. · Wong · A. H. C. · Mulsant · B. · Blumberger · D. · Courtney · D. · Husain · M. I. · Kurdyak · P. · Kleinman · R. A. · Torfason · A. · Gajaria · A. · Diaconescu · A. · Ma · A. · Sonley · A. · Abramovich · A. · Crawford · A. · Petronis · A. · Fage · B. · Orch
Introduction

Identifying individuals at risk of suicide remains an ongoing challenge. Previous research investigating risk factors for suicidal thoughts and behaviours (STB) has been informative for assessing suicide risk. However, the complex biological, psychological and sociocultural factors underlying STB have not been comprehensively captured to date, which has limited our understanding of how these factors interact to influence STB. Moreover, acute care settings, such as emergency departments (EDs), are often first points of contact for individuals with STB, highlighting a need for more research in these settings.

Methods and analysis

We aim to (1) characterize a cohort seeking care for STB and their clinical trajectories; (2) situate the cohort by comparing its characteristics and outcomes to other groups seeking emergency care; (3) explore their experiences of seeking care; and (4) examine blood-based biomarkers modulating risk for STB. Using a multimethod, prospective cohort design, we will follow up to 500 people aged 16 or older presenting to the ED with STB at a psychiatric hospital over 1 year. Analyses will involve descriptive statistics and latent profile analysis to characterize the cohort, hypothesis tests and regression models to situate the cohort, qualitative analysis based on a realist research framework to understand experiences, and within-participant comparisons of proteins, mRNA and epigenetic DNA modifications to examine biomarkers of contrasting states of STB.

Ethics and dissemination

This study was approved by the hospital’s Research Ethics Board with safeguards in place to ensure the well-being of participants and research team. An integrated knowledge translation approach will be used for dissemination, wherein patient and family advisors are engaged throughout each study phase. Findings will enhance our understanding of the multifactorial nature of suicide risk, inform strategies for prevention and provide important insights into characteristics, experiences and outcomes of individuals with STB, who are under-represented in mental health research.

Nurse Practitioner Conceptions of Capability Providing Medication and Safe Supply for Opioid Use Disorder in Primary Care: A Phenomenographic Study

ABSTRACT

Aims

To explore how nurse practitioners experienced and understood development of their capability providing medication for opioid use disorder and safe supply in North American primary care settings.

Design

A phenomenographic approach was applied to the study design, recruitment, and analysis.

Methods

Semi-structured interviews were conducted with 21 nurse practitioners via Zoom between July and September 2022 to elicit participant experiences and understanding of capability development when treating opioid use disorder. Participants worked in primary care settings in New England, United States and Ontario, Canada. Data was analysed using a phenomenographic approach.

Results

Five categories of description representing conceptions of capability development in treating opioid use disorder were identified through iterative data analysis. Capability development was experienced as a process of developing foundational practice knowledge; integrating knowledge with existing practices; evolving practice perspectives; adaptation of practice and becoming expert.

Conclusion

Capability attributes included creative thinking, risk taking and adapting existing practice in the service of person-centered care and harm reduction.

Implications for the Profession and Patient Care

Nurse practitioners have potential to increase access to treatment for opioid use disorder and demonstrated ability and willingness to engage in this work.

Impact

Nurse practitioners' participation as experts and leaders may be further leveraged in practice and policy development to enhance access to opioid use disorder treatment in primary care settings, including mentoring newer prescribers.

Reporting Method

Consolidated Criteria for Reporting Qualitative Studies (COREQ) EQUATOR guideline.

Patient and Public Contribution

There were no patient or public contributions to this research study.

The role community‐based healthcare providers play in managing hard‐to‐heal wounds

Abstract

It is common for community-based healthcare providers (CHPs)—many of whom have not received specialised training in wound care—to deliver initial and ongoing management for various wound types and diverse populations. Wounds in any setting can rapidly transition to a stalled, hard-to-heal wound (HTHW) that is not following a normal healing trajectory. Failure to recognise or address issues that cause delayed healing can lead to increased costs, healthcare utilisation and suffering. To encourage early intervention by CHPs, a panel of wound care experts developed actionable evidence-based recommendations for CHPs delineating characteristics and appropriate care in identifying and treating HTHWs. A HTHW is a wound that fails to progress towards healing with standard therapy in an orderly and timely manner and should be referred to a qualified wound care provider (QWCP) for advanced assessment and diagnosis if not healed or reduced in size by 40%–50% within 4 weeks. HTHWs occur in patients with multiple comorbidities, and display increases in exudate, infection, devitalised tissue, maceration or pain, or no change in wound size. CHPs can play an important initial role by seeing the individual's HTHW risk, addressing local infection and providing an optimal wound environment. An easy-to-follow one-page table was developed for the CHP to systematically identify, evaluate and treat HTHWs, incorporating a basic toolkit with items easily obtainable in common office/clinic practice settings. A flow chart using visual HTHW clinical cues is also presented to address CHPs with different learning styles. These tools encourage delivery of appropriate early interventions that can improve overall healthcare efficiency and cost.

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