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AnteayerBMJ Open

Virological, serological and clinical outcomes in chronic hepatitis B virus infection: development and validation of the HEPA-B simulation model

Por: Mohareb · A. M. · Kim · A. Y. · Boyd · A. · Noubary · F. · Kouame · M. G. · Anglaret · X. · Coffie · P. A. · Eholie · S. P. · Freedberg · K. A. · Hyle · E. P.
Objectives

Detailed simulation models are needed to assess strategies for prevention and treatment of hepatitis B virus (HBV) infection, the world’s leading cause of liver disease. We sought to develop and validate a simulation model of chronic HBV that incorporates virological, serological and clinical outcomes.

Methods

We developed a novel Monte Carlo simulation model (the HEPA-B Model) detailing the natural history of chronic HBV. We parameterised the model with epidemiological data from the Western Pacific and sub-Saharan Africa. We simulated the evolution of HBV DNA, ‘e’ antigen (HBeAg) and surface antigen (HBsAg). We projected incidence of HBeAg loss, HBsAg loss, cirrhosis, hepatocellular carcinoma (HCC) and death over 10-year and lifetime horizons. We stratified outcomes by five HBV DNA categories at the time of HBeAg loss, ranging from HBV DNA106 copies/mL. We tested goodness of fit using intraclass coefficients (ICC).

Results

Model-projected incidence of HBeAg loss was 5.18% per year over lifetime (ICC, 0.969 (95% CI: 0.728 to 0.990)). For people in HBeAg-negative phases of infection, model-projected HBsAg loss ranged from 0.78% to 3.34% per year depending on HBV DNA level (ICC, 0.889 (95% CI: 0.542 to 0.959)). Model-projected incidence of cirrhosis was 0.29–2.09% per year (ICC, 0.965 (95% CI: 0.942 to 0.979)) and HCC incidence was 0.06–1.65% per year (ICC, 0.977 (95% CI: 0.962 to 0.986)). Over a lifetime simulation of HBV disease, mortality rates were higher for people with older age, higher HBV DNA level and liver-related complications, consistent with observational studies.

Conclusions

We simulated HBV DNA-stratified clinical outcomes with the novel HEPA-B Model and validated them to observational data. This model can be used to examine strategies of HBV prevention and management.

Caregivers with limited language proficiency and their satisfaction with paediatric emergency care related to the use of professional interpreters: a mixed methods study

Por: Gmünder · M. · Gessler · N. · Buser · S. · Feuz · U. · Fayyaz · J. · Jachmann · A. · Keitel · K. · Brandenberger · J.
Objectives

Communication is a main challenge in migrant health and essential for patient safety. The aim of this study was to describe the satisfaction of caregivers with limited language proficiency (LLP) with care related to the use of interpreters and to explore underlying and interacting factors influencing satisfaction and self-advocacy.

Design

A mixed-methods study.

Setting

Paediatric emergency department (PED) at a tertiary care hospital in Bern, Switzerland.

Participants and methods

Caregivers visiting the PED were systematically screened for their language proficiency. Semistructured interviews were conducted with all LLP-caregivers agreeing to participate and their administrative data were extracted.

Results

The study included 181 caregivers, 14 of whom received professional language interpretation. Caregivers who were assisted by professional interpretation services were more satisfied than those without (5.5 (SD)±1.4 vs 4.8 (SD)±1.6). Satisfaction was influenced by five main factors (relationship with health workers, patient management, alignment of health concepts, personal expectations, health outcome of the patient) which were modulated by communication. Of all LLP-caregivers without professional interpretation, 44.9% were satisfied with communication due to low expectations regarding the quality of communication, unawareness of the availability of professional interpretation and overestimation of own language skills, resulting in low self-advocacy.

Conclusion

The use of professional interpreters had a positive impact on the overall satisfaction of LLP-caregivers with emergency care. LLP-caregivers were not well—positioned to advocate for language interpretation. Healthcare providers must be aware of their responsibility to guarantee good-quality communication to ensure equitable quality of care and patient safety.

Rationale and design of the THIRST Alert feasibility study: a pragmatic, single-centre, parallel-group randomised controlled trial of an interruptive alert for oral fluid restriction in patients treated with intravenous furosemide

Por: Chen · Y. · Shah · A. · Jani · Y. · Higgins · D. · Saleem · N. · Chafer · K. · Sydes · M. R. · Asselbergs · F. W. · Lumbers · R. T.
Introduction

Acute heart failure (HF) is a major cause of unplanned hospitalisation characterised by excess body water. A restriction in oral fluid intake is commonly imposed on patients as an adjunct to pharmacological therapy with loop diuretics, but there is a lack of evidence from traditional randomised controlled trials (RCTs) to support the safety and effectiveness of this intervention in the acute setting.

This study aims to explore the feasibility of using computer alerts within the electronic health record (EHR) system to invite clinical care teams to enrol patients into a pragmatic RCT at the time of clinical decision-making. It will additionally assess the effectiveness of using an alert to help address the clinical research question of whether oral fluid restriction is a safe and effective adjunct to pharmacological therapy for patients admitted with fluid overload.

Methods and analysis

THIRST (Randomised Controlled Trial within the electronic Health record of an Interruptive alert displaying a fluid Restriction Suggestion in patients with the treatable Trait of congestion) Alert is a single-centre, parallel-group, open-label pragmatic RCT embedded in the EHR system that will be conducted as a feasibility study at an National Health Service (NHS) hospital in London. The clinical care team will be invited to enrol suitable patients in the study using a point-of-care alert with a target sample size of 50 patients. Enrolled patients will then be randomised to either restricted or unrestricted oral fluid intake. Two primary outcomes will be explored (1) the proportion of eligible patients enrolled in the study and (2) the mean difference in oral fluid intake between randomised groups. A series of secondary outcomes are specified to evaluate the effectiveness of the alert, adherence to the randomised treatment allocation and the quality of data generated from routine care, relevant to the outcomes of interest.

Ethics and dissemination

This study was approved by Riverside Research Ethics Committee (Ref: 22/LO/0889) and will be published on completion.

Trial registration number

NCT05869656.

Serotype 3 Experimental Human Pneumococcal Challenge (EHPC) study protocol: dose ranging and reproducibility in a healthy volunteer population (challenge 3)

Por: Hazenberg · P. · Robinson · R. E. · Farrar · M. · Solorzano · C. · Hyder-Wright · A. · Liatsikos · K. · Brunning · J. · Fleet · H. · Bettam · A. · Howard · A. · Kenny-Nyazika · T. · Urban · B. · Mitsi · E. · El Safadi · D. · Davies · K. · Lesosky · M. · Gordon · S. B. · Ferreira · D. M.
Introduction

Since the introduction of pneumococcal conjugate vaccines, pneumococcal disease rates have declined for many vaccine-type serotypes. However, serotype 3 (SPN3) continues to cause significant disease and is identified in colonisation epidemiological studies as one of the top circulating serotypes in adults in the UK. Consequently, new vaccines that provide greater protection against SPN3 colonisation/carriage are urgently needed. The Experimental Human Pneumococcal Challenge (EHPC) model is a unique method of determining pneumococcal colonisation rates, understanding acquired immunity, and testing vaccines in a cost-effective manner. To enhance the development of effective pneumococcal vaccines against SPN3, we aim to develop a new relevant and safe SPN3 EHPC model with high attack rates which could be used to test vaccines using small sample size.

Methods and analysis

This is a human challenge study to establish a new SPN3 EHPC model, consisting of two parts. In the dose-ranging/safety study, cohorts of 10 healthy participants will be challenged with escalating doses of SPN3. If first challenge does not lead into colonisation, participants will receive a second challenge 2 weeks after. Experimental nasopharyngeal (NP) colonisation will be determined using nasal wash sampling. Using the dose that results in ≥50% of participants being colonised, with a high safety profile, we will complete the cohort with another 33 participants to check for reproducibility of the colonisation rate. The primary outcome of this study is to determine the optimal SPN3 dose and inoculation regime to establish the highest rates of NP colonisation in healthy adults. Secondary outcomes include determining density and duration of experimental SPN3 NP colonisation and characterising mucosal and systemic immune responses to SPN3 challenge.

Ethics and dissemination

This study is approved by the NHS Research and Ethics Committee (reference 22/NW/0051). Findings will be published in peer-reviewed journals and reports will be made available to participants.

Risk factors for SARS-CoV-2 infection: a test-negative case-control study with additional population controls in Norway

Por: Sarjomaa · M. · Zhang · C. · Tveten · Y. · Kersten · H. · Reiso · H. · Eikeland · R. · Kongerud · J. · Berg · K. K. · Thilesen · C. · Nordbo · S. A. · Aaberge · I. S. · Vandenbroucke · J. · Pearce · N. · Fell · A. K. M.
Objectives

This study aims to assess risk factors for SARS-CoV-2 infection by combined design; first comparing positive cases to negative controls as determined by PCR testing and then comparing these two groups to an additional prepandemic population control group.

Design and setting

Test-negative design (TND), multicentre case–control study with additional population controls in South-Eastern Norway.

Participants

Adults who underwent SARS-CoV-2 PCR testing between February and December 2020. PCR-positive cases, PCR-negative controls and additional age-matched population controls.

Primary outcome measures

The associations between various risk factors based on self- reported questionnaire and SARS-CoV-2 infection comparing PCR-positive cases and PCR-negative controls. Using subgroup analysis, the risk factors for both PCR-positive and PCR-negative participants were compared with a population control group.

Results

In total, 400 PCR-positive cases, 719 PCR-negative controls and 14 509 population controls were included. Male sex was associated with the risk of SARS-CoV-2 infection only in the TND study (OR 1.9, 95% CI 1.4 to 2.6), but not when PCR-positive cases were compared with population controls (OR 1.2, 95% CI 0.9. to 1.5). Some factors were positively (asthma, wood heating) or negatively (hypertension) associated with SARS-CoV-2 infection when PCR-positive cases were compared with population controls, but lacked convincing association in the TND study. Smoking was negatively associated with the risk of SARS-CoV-2 infection in both analyses (OR 0.5, 95% CI 0.3 to 0.8 and OR 0.6, 95% CI 0.4 to 0.8).

Conclusions

Male sex was a possible risk factor for SARS-CoV-2 infection only in the TND study, whereas smoking was negatively associated with SARS-CoV-2 infection in both the TND study and when using population controls. Several factors were associated with SARS-CoV-2 infection when PCR-positive cases were compared with population controls, but not in the TND study, highlighting the strength of combining case–control study designs during the pandemic.

Trends in COPD mortality from 1983 to 2018: protocol for a population-based cohort study in Denmark

Por: Sikjaer · M. G. · Hilberg · O. · Ibsen · R. · Lokke · A.
Introduction

Chronic obstructive pulmonary disease (COPD) is one of the leading causes of death worldwide, which is partly contributed to the increasing prevalence of COPD owning to a demographic shift towards an older population. Conversely, recent studies on COPD mortality that take this demographic shift in age into account find decreasing overall age-standardised COPD mortality rates over time. This decrease in the age-standardised COPD mortality rate is contributed advances in COPD diagnostics and treatment, decreasing smoking prevalence and general advances in medical care particularly in western countries. However, it is unknown if patients with COPD have experienced a comparable relative increase in survival in line with the general population.

Hence, there is a need for longitudinal studies comparing trends in mortality in patients with COPD compared with matched non-COPD individuals from the background population.

Methods and analyses

This is a cohort study with a matched non-COPD comparator cohort. Data are retrieved from the Danish national registers. Data from multiple registries from 1983 to 2018 will be merged on an individual level using the 10-digit Civil Registration numbers that are unique to each citizen in Denmark. Time trends in mortality in patients with COPD compared with the matched comparator cohort will be examined in three study periods: 1983–1993, 1994–2007 and 2008–2018.

Ethics and dissemination

The study is entirely based on registry data and ethical approval is not required according to Danish Law and National Ethics Committee Guidelines. The results will be published in peer-reviewed journals and reported at appropriate national and international conferences.

RELEASE-HF study: a protocol for an observational, registry-based study on the effectiveness of telemedicine in heart failure in the Netherlands

Por: van Eijk · J. · Luijken · K. · Jaarsma · T. · Reitsma · J. B. · Schuit · E. · Frederix · G. W. J. · Derks · L. · Schaap · J. · Rutten · F. H. · Brugts · J. · de Boer · R. A. · Asselbergs · F. W. · Trappenburg · J. C. A. · RELEASE-HF Investigators · Jan Borleffs · Dalen · Erol-Yilmaz
Introduction

Meta-analyses show postive effects of telemedicine in heart failure (HF) management on hospitalisation, mortality and costs. However, these effects are heterogeneous due to variation in the included HF population, the telemedicine components and the quality of the comparator usual care. Still, telemedicine is gaining acceptance in HF management. The current nationwide study aims to identify (1) in which subgroup(s) of patients with HF telemedicine is (cost-)effective and (2) which components of telemedicine are most (cost-)effective.

Methods and analysis

The RELEASE-HF (‘REsponsible roLl-out of E-heAlth through Systematic Evaluation – Heart Failure’) study is a multicentre, observational, registry-based cohort study that plans to enrol 6480 patients with HF using data from the HF registry facilitated by the Netherlands Heart Registration. Collected data include patient characteristics, treatment information and clinical outcomes, and are measured at HF diagnosis and at 6 and 12 months afterwards. The components of telemedicine are described at the hospital level based on closed-ended interviews with clinicians and at the patient level based on additional data extracted from electronic health records and telemedicine-generated data. The costs of telemedicine are calculated using registration data and interviews with clinicians and finance department staff. To overcome missing data, additional national databases will be linked to the HF registry if feasible. Heterogeneity of the effects of offering telemedicine compared with not offering on days alive without unplanned hospitalisations in 1 year is assessed across predefined patient characteristics using exploratory stratified analyses. The effects of telemedicine components are assessed by fitting separate models for component contrasts.

Ethics and dissemination

The study has been approved by the Medical Ethics Committee 2021 of the University Medical Center Utrecht (the Netherlands). Results will be published in peer-reviewed journals and presented at (inter)national conferences. Effective telemedicine scenarios will be proposed among hospitals throughout the country and abroad, if applicable and feasible.

Trial registration number

NCT05654961.

Distribution of intranasal naloxone to potential opioid overdose bystanders in Sweden: effects on overdose mortality in a full region-wide study

Por: Hakansson · A. · Alanko Blome · M. · Isendahl · P. · Landgren · M. · Malmqvist · U. · Troberg · K.
Objectives

Distribution of take-home naloxone is suggested to reduce opioid-related fatalities, but few studies have examined the effects on overdose deaths in the general population of an entire community. This study aimed to assess the effects on overdose deaths of a large-scale take-home naloxone programme starting in June 2018, using an observational design with a historic control period.

Design

From the national causes of death register, deaths diagnosed as X42 or Y12 (International Classification of Diseases, 10th revision, ICD-10) were registered as overdoses. Numbers of overdoses were calculated per 100 000 inhabitants in the general population, and controlled for data including only individuals with a prior substance use disorder in national patient registers, to focus on effects within the primary target population of the programme. The full intervention period (2019–2021) was compared with a historic control period (2013–2017).

Setting

Skåne county, Sweden.

Participants

General population.

Interventions

Large-scale take-home naloxone distribution to individuals at risk of overdose.

Primary and secondary outcome measures

Decrease in overdose deaths per 100 000 inhabitants, in total and within the population with substance use disorder diagnosis.

Results

Annual average number of overdose deaths decreased significantly from 3.9 to 2.8 per 100 000 inhabitants from the control period to the intervention period (a significant decrease in men, from 6.7 to 4.3, but not in women, from 1.2 to 1.3). Significant changes remained when examining only prior substance use disorder patients, and decreases in overdose deaths could not be attributed to a change in treatment needs for opioid use disorders in healthcare and social services.

Conclusions

The present study, involving 3 years of take-home naloxone distribution, demonstrated a decreased overdose mortality in the population, however, only in men. The findings call for further implementation of naloxone programmes, and for further studies of potential effects and barriers in women.

Trial registration number

NCT03570099.

Meeting high-risk patient pain care needs through intensive primary care: a secondary analysis

Por: Giannitrapani · K. F. · Holliday · J. R. · McCaa · M. D. · Stockdale · S. · Bergman · A. A. · Katz · M. L. · Zulman · D. M. · Rubenstein · L. V. · Chang · E. T.
Objective

Chronic pain disproportionately affects medically and psychosocially complex patients, many of whom are at high risk of hospitalisation. Pain prevalence among high-risk patients, however, is unknown, and pain is seldom a focus for improving high-risk patient outcomes. Our objective is to (1) evaluate pain frequency in a high-risk patient population and (2) identify intensive management (IM) programme features that patients and providers perceive as important for promoting patient-centred pain care within primary care (PC)-based IM.

Design

Secondary observational analysis of quantitative and qualitative evaluation data from a multisite randomised PC-based IM programme for high-risk patients.

Setting

Five integrated local Veterans Affairs (VA) healthcare systems within distinct VA administrative regions.

Participants

Staff and high-risk PC patients in the VA.

Intervention

A multisite randomised PC-based IM programme for high-risk patients.

Outcome measures

(a) Pain prevalence based on VA electronic administrative data and (b) transcripts of interviews with IM staff and patients that mentioned pain.

Results

Most (70%, 2593/3723) high-risk patients had at least moderate pain. Over one-third (38%, 40/104) of the interviewees mentioned pain or pain care. There were 89 pain-related comments addressing IM impacts on pain care within the 40 interview transcripts. Patient-identified themes were that IM improved communication and responsiveness to pain. PC provider-identified themes were that IM improved workload and access to expertise. IM team member-identified themes were that IM improved pain care coordination, facilitated non-opioid pain management options and mitigated provider compassion fatigue. No negative IM impacts on pain care were mentioned.

Conclusions

Pain is common among high-risk patients. Future IM evaluations should consider including a focus on pain and pain care, with attention to impacts on patients, PC providers and IM teams.

Social deprivation and exclusion in Parkinsons disease: a cross-sectional and longitudinal study

Por: Heimrich · K. G. · Schönenberg · A. · Prell · T.
Objective

To describe prevalence and associated factors of social deprivation in people with Parkinson’s disease (PwPD).

Design

Cross-sectional and longitudinal cohort study.

Setting

Data were taken from the Survey of Health, Ageing and Retirement in Europe (SHARE), a multidisciplinary, cross-national and longitudinal research project.

Participants

Community-dwelling adults from waves 5 (2013, n=66 188) and 6 (2015, n=68 186) of the SHARE dataset. After longitudinal analyses, participants in wave 5 can be retrospectively divided into the following three subgroups: PwPD at wave 5 (n=559), people newly reported PD from wave 5 to wave 6 (prodromal PD; n=215) and people without PD (n=46 737).

Outcome measures

The prevalence and associated factors of social deprivation in PD, its impact on quality of life (QoL) and its onset within the course of PD.

Results

PwPD had higher indices for material and social deprivation than non-PD participants, and 20% of PwPD were at risk of social exclusion. Social deprivation alone accounted for 35% and material deprivation for 21% of QoL variance and remained significant predictors of QoL after adjustment for cofactors. Social deprivation and risk of social exclusion were already increased in people with prodromal PD, and accordingly preceded PD diagnosis in wave 6.

Conclusions

For the treatment of PD, we should consider the impact of social deprivation and exclusion on QoL and their association with mental and physical functioning. However, the relevance of social deprivation as a prodromal phenomenon requires further investigation.

Use of Artificial Intelligence in the Identification and Management of Frailty: A Scoping Review Protocol

Por: Karunananthan · S. · Rahgozar · A. · Hakimjavadi · R. · Yan · H. · Dalsania · K. A. · Bergman · H. · Ghose · B. · LaPlante · J. · McCutcheon · T. · McIsaac · D. I. · Abbasgholizadeh Rahimi · S. · Sourial · N. · Thandi · M. · Wong · S. T. · Liddy · C.
Introduction

Rapid population ageing and associated health issues such as frailty are a growing public health concern. While early identification and management of frailty may limit adverse health outcomes, the complex presentations of frailty pose challenges for clinicians. Artificial intelligence (AI) has emerged as a potential solution to support the early identification and management of frailty. In order to provide a comprehensive overview of current evidence regarding the development and use of AI technologies including machine learning and deep learning for the identification and management of frailty, this protocol outlines a scoping review aiming to identify and present available information in this area. Specifically, this protocol describes a review that will focus on the clinical tools and frameworks used to assess frailty, the outcomes that have been evaluated and the involvement of knowledge users in the development, implementation and evaluation of AI methods and tools for frailty care in clinical settings.

Methods and analysis

This scoping review protocol details a systematic search of eight major academic databases, including Medline, Embase, PsycInfo, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Ageline, Web of Science, Scopus and Institute of Electrical and Electronics Engineers (IEEE) Xplore using the framework developed by Arksey and O’Malley and enhanced by Levac et al and the Joanna Briggs Institute. The search strategy has been designed in consultation with a librarian. Two independent reviewers will screen titles and abstracts, followed by full texts, for eligibility and then chart the data using a piloted data charting form. Results will be collated and presented through a narrative summary, tables and figures.

Ethics and dissemination

Since this study is based on publicly available information, ethics approval is not required. Findings will be communicated with healthcare providers, caregivers, patients and research and health programme funders through peer-reviewed publications, presentations and an infographic.

Registration details

OSF Registries (https://doi.org/10.17605/OSF.IO/T54G8).

Financial burden of postoperative complications following oesophagectomy: a scoping review protocol

Por: Buchholz · V. · Berman · J. · Liu · D. · Le · P. · Weinberg · L.
Introduction

The rapid rise in the incidence of oesophageal adenocarcinoma has resulted in an increasing number of patients undergoing oesophagectomy. Although novel surgical techniques are enhancing surgical outcomes, postoperative complications remain pervasive. Despite this, there are limited reviews mapping the cost of postoperative complications following oesophagectomy, and none has compared cost differences between patient groups. Such information would be invaluable in appreciating the financial burden on the healthcare system and serving to guide hospital financing decisions. This scoping review protocol outlines an approach to reviewing the literature to precipitate and inform discussions surrounding financing oesophagectomy procedures as well as funding requirements for upper gastrointestinal surgical units.

Methods and analysis

Adhering to the pertinent components of the Preferred Reporting Items for Systematic Review and Meta-Analysis Extension for Scoping Review Protocols guidelines, a systematic exploration will be conducted across electronic databases, including MEDLINE, EMBASE, the Cochrane Library and Econolit, with further reference tracking of eligible studies. This review will encompass studies related to the costs associated with complications following oesophagectomy. All studies published prior to 31 October 2023 are eligible for inclusion. The process of screening and extracting data will be undertaken by two independent reviewers. Subsequently, the amassed data will be pooled and subjected to comprehensive analysis and presented descriptively, using both a mixed methods and a narrative approach.

Ethics and dissemination

Ethics approval was not required. The results will be communicated through established professional networks, conference presentations and publication in peer-reviewed journals.

Assessing the feasibility of a randomised controlled trial examining the effect of hearing aids on cognitive decline in elderly individuals: a study protocol

Por: Fuchten · D. · Smit · A. L. · Huenges Wajer · I. M. C. · Rhebergen · K. S. · Stegeman · I.
Introduction

Hearing loss is one of the leading potentially modifiable risk factors for dementia. There is growing evidence suggesting that treating hearing loss with hearing aids could be a relatively low-cost intervention in reducing cognitive decline and the risk of dementia in the long term. However, given the current constraints of the limited evidence, it is premature to draw definitive conclusions about the effect of hearing aids on cognitive functioning. More long-term randomised studies examining this effect would be recommended. Prior to embarking on large-scale lengthy randomised controlled trials (RCTs), it is imperative to determine the viability of such studies. Therefore, the purpose of the current study is to assess the feasibility of a RCT that investigates the effect of hearing aids on cognitive functioning in elderly hearing impaired individuals.

Methods and analysis

In this randomised controlled feasibility trial, 24 individuals aged 65 years or older with mild to moderate hearing loss (≥35–

Ethics and dissemination

This research protocol was approved by the Institutional Review Board of the University Medical Centre Utrecht (NL80594.041.22, V.3, January 2023). The trial results will be made accessible to the public in a peer-reviewed journal.

Trial registration number

ISRCTN84550071.

Prevalence of psychological distress in nurses, physicians and leaders working in intensive care units during the COVID-19 pandemic: a national one-year follow-up study

Por: Hovland · I. S. · Skogstad · L. · Stafseth · S. · Hem · E. · Diep · L. M. · Raeder · J. · Ekeberg · O. · Lie · I.
Objective

To report and compare psychological distress as symptoms of anxiety, depression and post-traumatic stress among intensive care units’ (ICU) nurses, physicians and leaders at 12 months after the baseline survey (spring 2020), during the COVID-19 pandemic in Norway. Furthermore, to analyse which baseline demographic and COVID ICU-related factors have a significant impact on psychological distress at 12 months.

Design

Prospective, longitudinal, observational cohort study.

Setting

Nationwide, 27 of 28 hospitals with COVID ICUs in Norway.

Participants

Nurses, physicians and their leaders. At 12 month follow-up 287 (59.3%) of 484 baseline participants responded.

Primary and secondary outcome measures

Symptoms of anxiety and depression using the Hopkins Symptoms Checklist-10 (HSCL-10). Symptoms of post-traumatic stress using the post-traumatic stress disease checklist for the Diagnostic and Statistical Manual of Mental Disorders 5 (PCL-5).

Demographics (included previous symptoms of anxiety and depression) and COVID ICU-related factors (professional preparations, emotional experience and support) impacting distress at 12 months.

Results

Psychological distress, defined as caseness on either or both HSCL-10 and PCL-5, did not change significantly and was present for 13.6% of the participants at baseline and 13.2% at 12 month follow-up. Nurses reported significantly higher levels of psychological distress than physicians and leaders. Adjusted for demographics and the COVID ICU-related factors at baseline, previous symptoms of depression and fear of infection were significantly associated with higher levels of anxiety and depression at 12 months. Previous symptoms of depression, fear of infection and feeling of loneliness was significantly associated with more symptoms of post-traumatic stress.

Conclusion

One year into the COVID-19 pandemic 13.2% of the ICUs professionals reported psychological distress, more frequently among the nurses. Fear of infection, loneliness and previous symptoms of depression reported at baseline were associated with higher levels of distress. Protective equipment and peer support are recommended to mitigate distress.

Trial registration number

ClinicalTrials.gov. Identifier: NCT04372056.

Study protocol for a feasibility study of microinterventions in smartphone-based assessments to reduce depressive rumination

Por: Höller · I. · Spangenberg · L.
Introduction

Depression as well as suicidal ideation and behaviours share several precipitating and maintaining factors and are subject to the influence of overlapping constructs. One of these transdiagnostic constructs is rumination. For the treatment of rumination, a variety of interventions are already available. However, not everyone with a need receives psychotherapeutic treatment. And even if they do: implementing learnt strategies alone at home can be challenging for patients. Therefore, this study aims to test the feasibility of delivering microinterventions for the reduction of rumination in a smartphone-based setting with the goal to make these interventions accessible to a larger number of people and support their use in everyday life.

Methods and analysis

The study’s design is an uncontrolled-within-group design. Participants with at least mild depressive symptoms and reported rumination will be included and recruited via outpatient clinics as well as in the general population. The aim is to recruit at least N=70 participants. Participants first undergo a short telephone screening, a baseline assessment, a 7-day smartphone-based assessment including microinterventions in case participants report rumination and a postassessment. For feasibility purposes, primary outcomes relate to participants’ compliance, their evaluation of the smartphone-based assessment as well as the microinterventions delivered during the assessment. As a secondary goal, clinical utility will be examined. Clinical outcomes (eg, depressive symptoms, rumination) will be measured at baseline and postassessment.

Ethics and dissemination

The ethics committee of the institute of psychology of the university of Duisburg-Essen and University of Leipzig has approved the study. Study results will be disseminated to healthcare communities, in peer-reviewed science journals and at conferences.

Trial registration number

DRKS00031743.

Experiences of individuals with rheumatoid arthritis interacting with health care and the use of a digital self-care application: a qualitative interview study

Por: Viberg Johansson · J. · Blyckert · H. · Schölin Bywall · K.
Objectives

Over the last few decades, there have been significant improvements in the treatment of rheumatoid arthritis (RA), with the development of new treatments and guidelines for teamwork and patient self-care and access to digital tools. This study aimed to explore the experiences of individuals with RA interacting with healthcare. It also looked at how a self-care application, an educational programme called the ‘healthcare encounter’, improved patient–doctor communication.

Design

Semistructured interviews were conducted, and qualitative content analysis was performed.

Setting

The potential participants, individuals with established, or under investigation for, RA diagnosis at rheumatology clinics in Sweden, were asked to participate in the study via a digital self-care application called the Elsa Science Self-care app.

Participants

Ten interviews were performed with participants from nine clinics following a meeting with the rheumatologist or other healthcare personnel between September 2022 and October 2022. Phrases, sentences or paragraphs referring to experiences from healthcare meetings and opinions about the digital programme were identified and coded. Codes that reflected similar concepts were grouped; subcategories were formulated, and categories were connected to their experiences and opinions.

Results

Among our participants, three main categories emerged: the availability of healthcare, individual efforts to have a healthier life and personal interaction with healthcare. Participants described that the ‘healthcare encounter’ educational programme can be a source of information, which confirms, supports and creates a sense of control.

Conclusion

The participants valued being seen and taking part in a dialogue when they had prepared themselves (observed symptoms over time and prepared questions). The implementation of digital self-care applications might need to be incorporated into the healthcare setting, so that both the patients and the healthcare personnel have a shared understanding. Collaboration is essential in this context.

Self-Management Analysis in Chronic Conditions (SMACC) checklist: an international consensus-based tool to develop, compare and evaluate self-management support programmes

Por: Moreels · T. · Cruyt · E. · De Baets · S. · Andries · L. · Arts-Tielemans · M. · Rodriguez-Bailon · M. · Bergström · A. · Boete · K. · Bormans · I. · Costa · U. · Declercq · H. · Dekelver · S. · Dekyvere · V. · Delooz · E. · Engels · C. · Helderweirt · S. · Jarrey · M. · Lenaerts · A.
Objectives

The Self-Management Analysis in Chronic Conditions (SMACC) checklist was developed as a guidance tool to support the development, comparison and evaluation of self-management support programmes for persons with a chronic condition. The checklist was based on a previously performed concept analysis of self-management. The aim of this study was to validate its content using an international Delphi study and to deliver a final version.

Design

A two-round Delphi study was conducted between October 2022 and January 2023. Using the researchers’ networks, professionals with research or clinical expertise in self-management support and chronic conditions were recruited via online purposive snowball sampling. Participants were asked to score each item of the checklist (16 items total) on 3 content validity indicators: (1) clarity and comprehensibility, (2) relevance and importance and (3) degree of alignment with the overall goal of the checklist to promote adequate and comprehensive self-management support programmes. A consensus threshold of 75% agreement was used. The participants were also asked general questions about the checklist as a whole and were asked to provide feedback considering its refinement.

Results

Fifty-four professionals with an average 14.5 years of experience participated in round 1, 48 with an average 12.5 years of experience participated in round 2. The majority of professionals were from Western Europe. For the majority of items consensus was reached after round 1. In round 2, 3 of the 4 remaining items reached consensus, 1 last item was retained based on highly recurring feedback.

Conclusions

The SMACC checklist was considered a valid and comprehensive tool to aid the development, evaluation and comparison of self-management support programmes. It was acknowledged as a useful instrument to supplement existing frameworks and was seen as feasible to implement in both research and clinical settings. Further validation in the field, with input from patients and peer experts, will be valuable.

Prognostic value of acute National Institutes of Health Stroke Scale Items on disability: a registry study of first-ever stroke in the western part of Sweden

Por: Hagberg · G. · Ihle-Hansen · H. · Abzhandadze · T. · Reinholdsson · M. · Hansen · H. I. · Sunnerhagen · K. S.
Objectives

We aimed to study how the individual items of the National Institutes of Health Stroke Scale (NIHSS) at admission predict functional independence 3 months post-stroke in patients with first-ever stroke.

Setting

This registry-based study used data from two Swedish stroke registers (Riksstroke, the mandatory national quality register for stroke care in Sweden, and Väststroke, a local quality stroke register in Gothenburg).

Participants

This study included patients with first-ever acute stroke admitted from November 2014 to August 2018, with available NIHSS at admission and modified Rankin Scale (mRS) at 3-month follow-up.

Primary outcome

The primary outcome variable was mRS≤1 (defined as an excellent outcome) at 3-month follow-up.

Results

We included 1471 patients, mean age was 72 (± 14.5) years, 48% were female, and 66% had mild strokes (NIHSS≤3). In adjusted binary logistic regression analysis, the NIHSS items impaired right motor arm and leg, and impairment in visual field, reduced the odds of an excellent outcome at 3 months ((OR 0.60 (95% CI 0.37 to 0.98), OR 0.60 (95% CI 0.37 to 0.97), and OR 0.65 (95% CI 0.45 to 0.94)). When exploring the effect size of associations between NIHSS items and mRS≤1 p, orientation, language and right leg motor had the largest yet small association.

Conclusions

Stroke patients with scores on the NIHSS items right motor symptoms or visual field at admission are less likely to have an excellent outcome at 3 months. Clinicians should consider the NIHSS items affected, not only the total NIHSS score, both in treatment guidance and prognostics.

Effects of socioeconomic status on patient-reported outcome after surgically treated trigger finger: a retrospective national registry-based study

Por: Lesand · L. · Dahlin · L. B. · Rydberg · M. · Zimmerman · M.
Objectives

To investigate if socioeconomic status impacts patient-reported outcomes after a surgically treated trigger finger (TF).

Design and setting

Data on patients with TF treated with surgery were collected from the Swedish National Quality Registry of Hand Surgery (HAKIR) 2010–2019 with an evaluation of symptoms and disability before surgery and at 3 and 12 months after surgery, using the short version of the Disabilities of Arm, Shoulder and Hand (QuickDASH) questionnaire.

Data from HAKIR and the Swedish National Diabetes Registry (ndr.nu) were combined with socioeconomic data from Statistics Sweden (scb.sc), analysing the impact of marital status, education level, income, occupation, sickness benefits, days of unemployment, social assistance and migrant status on the outcome by a linear regression model.

Participants

In total, 5477 patients were operated on for primary TF during the study period, of whom 21% had diabetes, with a response rate of 35% preoperatively, 26% at 3 months and 25% at 12 months.

Results

At all time points, being born in Sweden (preoperatively B-coefficient: –9.74 (95% CI –13.38 to –6.11), 3 months postoperatively –9.80 (95% CI –13.82 to –5.78) and 12 months postoperatively –8.28 (95% CI –12.51 to –4.05); all p

Conclusion

Individuals with low earnings, high sick leave the same year as the surgery and those born outside of Sweden reported more symptoms both before and after surgery, but the relative improvement was not affected by socioeconomic factors.

Impact of an Acceptance and Commitment Therapy programme on HbA1c, self-management and psychosocial factors in adults with type 1 diabetes and elevated HbA1c levels: a randomised controlled trial

Por: Wijk · I. · Amsberg · S. · Johansson · U.-B. · Livheim · F. · Toft · E. · Anderbro · T.
Objective

To evaluate the impact of an Acceptance and Commitment Therapy (ACT) programme, tailored for people living with type 1 diabetes, on glycated haemoglobin (HbA1c), self-management and psychosocial factors among individuals with HbA1c>60 mmol/mol compared with treatment as usual (TAU).

Setting

An endocrinologic clinic in Sweden.

Participants

In this randomised controlled trial, 81 individuals with type 1 diabetes, aged 18–70 years with HbA1c>60 mmol/mol, were randomly assigned to either an ACT group intervention or TAU. Exclusion criteria were: unable to speak Swedish, untreated or severe psychiatric disease, cortisone treatment, untreated thyroid disease and newly started insulin pump therapy. At the 2-year follow-up, HbA1c was measured in 26 individuals.

Intervention

The ACT programme comprised seven 2-hour sessions held over 14 weeks and focused on acceptance of stressful thoughts and emotions, and to promote value-based committed action.

Outcomes

The primary outcome was HbA1c, and the secondary outcomes were measures of depression, anxiety, general stress, fear of hypoglycaemia, diabetes distress, self-care activities, psychological flexibility (general and related to diabetes) and quality of life. The primary endpoint was HbA1c 2 years after the intervention programme. Linear mixed models were used to test for an interaction effect between measurement time and group.

Results

Likelihood ratio test of nested models demonstrated no statistically significant interaction effect (2=0.49, p=0.485) between measurement time and group regarding HbA1c. However, a statistically significant interaction effect (likelihood ratio test 2=12.63, p

Conclusions

No statistically significant difference was found between the groups regarding the primary outcome measure, HbA1c. However, the ACT programme showed a persistent beneficial impact on psychological flexibility in the intervention group. The dropout rate was higher than expected, which may indicate a challenge in this type of study.

Trial registration number

NCT02914496.

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