Ethical Authority Research Articles

Health care workers’ qualitative descriptions of ethically challenging situations evoking moral distress during Covid-19

Background: The high public demand for healthcare services during the COVID-19 pandemic and strict infection control measures, coupled with threat of severe illness and death, and limited resources, led to many healthcare workers (HCWs) experiencing ethically challenging situations (ECSs). Objective: To systematically explore first-hand accounts of ECS-evoking moral distress among HCWs during this public health emergency. Research design: This was an open cohort study. All participants were asked whether they had been in ECS-evoking moral distress during the pandemic. Those who had were asked to describe these situations. Answers were systematically analyzed according to three levels of root causes for ECSs, using thematic analysis. Participants and research context: In January 2022, 977 HCWs from four Norwegian university hospitals participated. Ethical considerations: The study received ethical approval from the Norwegian Ethical Review Authority (No. 130944). Results: In total, 508 participants (52%) reported that they had experienced ECS-evoking moral distress during the pandemic, whereof 323 provided a qualitative description. We found that while a few reported ECSs caused at the patient level, and some described situations at the unit/team level, the vast majority reported situations caused at the system level, predominantly related to resource scarcity, particularly poor staffing. Conclusion: Our findings strongly indicate that efforts to mitigate moral distress among HCWs should be targeted at the system level. More specifically, the study findings highlight resource limitations, particularly poor staffing, as a major cause of moral distress during the pandemic.

Experiences of co-producing person-centred and cohesive clinical pathways in the national system for knowledge-based management in Swedish healthcare: a qualitative study

BackgroundWhen the 21 Swedish county councils decided to collaborate in the creation of a national system for knowledge-based management, patient participation was mandatory. Patient and next-of-kin representatives (PR) co-produced person-centred and cohesive clinical pathways together with healthcare professionals (HPR). Research on co-production in healthcare at the national level is scarce. The aim of this study is to explore experiences of patient participation from the perspectives of both PRs and HPRs when co-producing clinical pathways within the Swedish nationwide healthcare system for knowledge-based management.MethodsA qualitative study was conducted. A strategic sample of nine PRs and eight HPRs were interviewed individually between August 2022 and January 2023 using a semi-structured interview guide. We analysed data using an inductive content analysis.ResultsThree main categories were identified: (1) Finding appropriate patient representativeness; (2) Working methods that facilitate a patient perspective; and (3) Influence of the patient perspective in the clinical pathways.ConclusionsThe study demonstrates the importance of patient and next-of-kin participation in the construction of clinical pathways at the national level. The results provide a platform for further research on patient participation on the national level and add to studies on if and how patient participation on this level has an impact on how the clinical pathways are put into practice at the micro level, and the support provided at the meso level. The study contributes to the growing body of literature studying patient participation and co-production.Trial registrationRegion Örebro County ID 276,940. An advisory opinion was obtained from the Swedish Ethical Review Authority (2021-05899-01).

Ethical challenges in residential care facilities during COVID-19: Leaders' perspective.

Person-centred care is based on ethical principles, and it is regarded as high-quality care. Care of older persons should embrace person-centredness. During the pandemic, older persons were highlighted as a vulnerable group at risk of developing serious illness and/or suffering death from COVID-19. Several pandemic-related measures were introduced in residential care facilities (RCFs) to reduce this risk, which influenced the possibilities to lead and provide a person-centred care. This study's aim was to explore ethical challenges in relation to person-centredness during the COVID-19 pandemic, from the perspective of leaders in RCFs. The study had a qualitative descriptive design. Semi-structured interviews were conducted with 26 leaders working in RCFs in Sweden. Data were analysed using conventional content analysis. The study was approved by the Swedish Ethical Review Authority. The participants received oral and written information about the study and gave written consent. The study was conducted in accordance with the Declaration of Helsinki. The overarching ethical challenge was Having to disregard the individual needs of the person in order to protect the group and society. This included (a) Protecting the group versus promoting the older person's autonomy; (b) Being forced to lead care based on uncertainty instead of evidence; (c) Striving to provide dignified care but lacking opportunities; and (d) Going far beyond ordinary duty and endangering one's own and the staff's health. The ethical challenges meant being torn between the person's individual needs and protecting the group and society, with clashing ethical principles as a consequence. The leaders faced ethical situations resulting in undignified and compromised person-centred care, which has implications for stakeholders and management who need to address the work conditions in RCFs.

Internet-delivered cognitive–behaviour therapy for anxiety related to asthma: study protocol for a randomised controlled trial

IntroductionThere is an established association between asthma and anxiety. The overlap between asthma symptoms and symptoms of anxiety may cause individuals to overestimate their asthma severity and restrict their daily...

Protocol of a randomised controlled multicentre trial investigating the effectiveness and safety of a wilderness programme on the mental and physical well-being of adolescents and young adults affected by cancer: the WAYA-2 study

IntroductionAdolescents and young adults (AYAs) affected by cancer are an understudied group. Effective interventions are needed to support coping with the late effects of cancer, its treatment and to promote...

ØCD: protocol for the development and evaluation of a cognitive-behavioral prevention program for obsessive-compulsive disorder

BackgroundObsessive-compulsive disorder (OCD) imposes significant burdens on individuals, families, and healthcare systems and the COVID-19 pandemic appears to have exacerbated OCD symptoms. Currently, there are no validated prevention programs for OCD, highlighting a critical gap in mental health services. This study aims to develop and validate the first ØCD prevention program, for at-risk adults, utilizing cognitive-behavioral therapy (CBT) and exposure response prevention (ERP) techniques.MethodsA single-blind, randomized controlled trial comparing the ØCD prevention program to a waitlist control group will be conducted. Participants, at-risk adults (18–65 years) with subclinical OCD symptoms (OCI-R score ≥ 12), will be recruited for the study. The ØCD prevention program compresise of six online group sessions incorporating CBT and ERP techniques over three modules. The primary outcomes are OCD symptom severity (measured by the Obsessive-Compulsive Inventory- revised form; OCI-R), depression symptoms (measured by the Patient Health Questionnaire; PHQ-9), and anxiety symptoms (measured by the Generalised Anxiety Disorder 7-item; GAD-7). Secondary outcomes include OCD-related beliefs, experiential avoidance, resilience, quality of life, uncertainty intolerance, automatic thoughts, and distress. Outcome measures will be collected at baseline, at completion of the intervention, and one year later (follow-up). At follow-up, we will also analyze the OCD diagnostic incidence, using the Structured Clinical Interview for DSM-5. We will employ a multivariate analysis of variance (MANOVA) to explore whether significant differences exist between groups across dependent variables. To compare the OCD incidence levels from the pre-test to the follow-up we will use the chi-squared test.DiscusionThe present study may contribute novel data on the efficacy of OCD prevention approaches, leading to the development of an evidence-based OCD prevention program that could alleviate individual and societal burdens associated with OCD.Trial registrationThis trial was approved by the University Ethical Review Authority (937/ 28.11.2023) at Babeș-Bolyai University and is registered on clinicaltrials.gov (ID: NCT06262464).

Improving ethical assurance for non-university researchers in crisis settings: an early vision based on democratic norms

This article aims to open a discussion on better ethical assurance for non-university research actors drawing on democratic norms. It derives from the author’s experience of a gap in ethical assurance for social science and humanities (SSH) research that takes place outside academia, for example within international organisations, public bodies, non-governmental organisations (NGOs) and by private entities. Many of these actors commission, conduct or sub-contract research activities involving human participants on a regular basis, an activity that often increases during times of crisis where researchers in both the public and private sphere scramble to generate the new knowledge necessary to respond and prevent further harms. The ethical assurance frameworks for such research, while growing, remain limited. Discussion of research conducted by actors outside of university settings and their ethical assurance frameworks are both subjects under-interrogated within the literature. This paper seeks to open that discussion by presenting this broad non-university research context through the frame of research in crisis settings, where the ethical requirements of ‘do no harm’ and the ‘dual imperative’ possess an even heavier significance in research ethics. Furthermore, the global and diverse nature of crisis settings often gives rise to conversations concerning the positioning of the research actor and the need to empower the research participant. This paper presents an early vision of the non-university research actor and ethical assurance process based on the democratic norms of equality and inclusivity.

Novel AMI in Zigbee Satellite Network Based on Heterogeneous Wireless Sensor Network for Global Machine-to-Machine Connectivity

This study endeavored to enhance the efficiency and utility of microcomputer meters. In the past, their role was predominantly confined to remote meter reading, entailing high construction and communication transmission costs, coupled with subsequent maintenance and operational expenditures. These factors collectively impacted the enthusiasm of various stakeholders to invest in this realm. Hence, in alignment with the smart city development initiative, the natural gas industry has pioneered the establishment of an advanced metering infrastructure with heterogeneous wireless sensor networks (HWSNs) at its core. This visionary leap incorporates global machine-to-machine connectivity (G-M2MC) technology, interconnecting all facets of its operations, thereby positioning itself as a trailblazer within the industry. While advancing this endeavor, the project’s scheduling aligns with the enterprise’s sustainability goals in the early stages of digital transformation. This strategic allocation of resources is responsive to government policies and aspires to cultivate a digitally connected smart green energy hub, thereby expediting the transformation of the living environment. The objective is to provide a stable, secure, cost-effective, and reliable system that can be shared among peers. Furthermore, this study delved into the analysis of congestion avoidance in intelligent Zigbee satellite transport networks based on the HWSNs-GM2MC of non-synchronous satellite orbit system (NGSO) pivotal technologies, utilizing them to integrate the smart LNGas management system (SGMS). Concurrently, it developed application services through the smart meter application interface (SMAPI), distinct from conventional microcomputer meters. However, it is imperative to acknowledge that cloud computing, while processing sensitive data, grapples with issues of latency, privacy, efficiency, power consumption, and zero-trust security risk information management and ethical authority management capabilities in the defense of disaster relief responses.

Remote neuropsychological assessment of patients with neurological disorders and injuries—a study protocol for a cross-sectional case-control validation study

IntroductionThere are great potential benefits of being able to conduct neuropsychological assessments remotely, especially for hard-to-reach or less mobile patient groups. Such tools need to be equivalent to standard tests...

Trends in authorship in the Journal of Cutaneous Pathology, 1981-2020.

The increase in authors per scientific article in many different medical and scientific disciplines has raised concerns over ethical authorship. Trends in authorship in dermatopathology are unknown. Cross-sectional study of a random sample of 200 articles from the Journal of Cutaneous Pathology (1981-2020). The number of authors per article increased by an estimated 96% between 1981 and 2020 (2.7-5.3), while the relative citation ratio decreased by an estimated 56% during the same period (1.19-0.52). Higher author counts were not associated with higher relative citation ratios (p = 0.2349) or analytic study designs (p = 0.2987). Higher relative citation ratios were associated with analytic study designs (p = 0.0374). There has been significant growth in authorship credit at the journal without a corresponding increase in research impact or study rigor. Remedial measures to stem authorship inflation and promote more impactful studies may be necessary.

Study protocol for a prospective cohort study describing the injury characteristics in elite gymnasts in TeamGym: the Swedish TeamGym Injury Cohort – STIC

IntroductionGymnastics consists of several different disciplines, whereof TeamGym is one. TeamGym is a young discipline with sparse research. The aim of the study is to investigate the injury characteristics in...

Ethically Determining the Authorship of Health Science Research Publications: A Scoping Review

Authorship is a significant aspect of scientific research publications, serving as a primary means of acknowledging the intellectual contributions of individuals and shaping career trajectories. However, determining authorship ethically and fairly in health science research remains a complex and multifaceted issue. This scoping review aims to explore the existing literature surrounding ethical considerations associated with authorship determination in health science research publications, published between 1989 and 2023. A total of 25 studies met the inclusion criteria. The findings revealed that ethical authorship practices in health science research are complex and multifaceted. This review emphasized how crucial it is to have precise rules and guidelines for deciding who is the author in academic journals, research institutes, and societies. The International Committee of Medical Journal Editors (ICMJE) has published several ethical principles to address the difficulties associated with authorship determination. Still, there are differences and disagreements in how these rules are interpreted and applied, which could present moral enigmas. The review also examines new ethical issues arising from multidisciplinary and collaborative research, such as the responsibilities and funding of industry collaborations, shared authorship, and acknowledging the contributions of other groups. Maintaining the integrity of health science research and encouraging responsible collaboration requires making sure that authorship determination is transparent, equitable, and accountable. Authors should disclose any conflicts of interest that could influence their judgment or interpretation of the research findings.

Machine Learning Model for Readmission Prediction of Patients With Heart Failure Based on Electronic Health Records: Protocol for a Quasi-Experimental Study for Impact Assessment.

Care for patients with heart failure (HF) causes a substantial load on health care systems where a prominent challenge is the elevated rate of readmissions within 30 days following initial discharge. Clinical professionals face high levels of uncertainty and subjectivity in the decision-making process on the optimal timing of discharge. Unwanted hospital stays generate costs and cause stress to patients and potentially have an impact on care outcomes. Recent studies have aimed to mitigate the uncertainty by developing and testing risk assessment tools and predictive models to identify patients at risk of readmission, often using novel methods such as machine learning (ML). This study aims to investigate how a developed clinical decision support (CDS) tool alters the decision-making processes of health care professionals in the specific context of discharging patients with HF, and if so, in which ways. Additionally, the aim is to capture the experiences of health care practitioners as they engage with the system's outputs to analyze usability aspects and obtain insights related to future implementation. A quasi-experimental design with randomized crossover assessment will be conducted with health care professionals on HF patients' scenarios in a region located in the South of Sweden. In total, 12 physicians and nurses will be randomized into control and test groups. The groups shall be provided with 20 scenarios of purposefully sampled patients. The clinicians will be asked to take decisions on the next action regarding a patient. The test group will be provided with the 10 scenarios containing patient data from electronic health records and an outcome from an ML-based CDS model on the risk level for readmission of the same patients. The control group will have 10 other scenarios without the CDS model output and containing only the patients' data from electronic medical records. The groups will switch roles for the next 10 scenarios. This study will collect data through interviews and observations. The key outcome measures are decision consistency, decision quality, work efficiency, perceived benefits of using the CDS model, reliability, validity, and confidence in the CDS model outcome, integrability in the routine workflow, ease of use, and intention to use. This study will be carried out in collaboration with Cambio Healthcare Systems. The project is part of the Center for Applied Intelligent Systems Research Health research profile, funded by the Knowledge Foundation (2021-2028). Ethical approval for this study was granted by the Swedish ethical review authority (2022-07287-02). The recruitment process of the clinicians and the patient scenario selection will start in September 2023 and last till March 2024. This study protocol will contribute to the development of future formative evaluation studies to test ML models with clinical professionals. PRR1-10.2196/52744.

Multicentre randomised trial of screening with sFlt1/PlGF and planned delivery to prevent pre-eclampsia at term: protocol of the PE37 study

IntroductionPre-eclampsia affects ~5%–7% of pregnancies. Although improved obstetric care has significantly diminished its associated maternal mortality, it remains a leading cause of maternal morbidity and mortality in the world. Term...

Factors influencing satisfaction with prosthetic and orthotic services – a national cross-sectional study in Sweden

Purpose To evaluate client satisfaction with prosthetic and orthotic services in Sweden, determine if satisfaction differs between clients using different devices and identify factors which influence client satisfaction. Materials and methods A cross-sectional design was used to survey 7318 clients. The survey included items related to demographics, quality of life, device comfort, device use, the extent to which clients’ needs were met and satisfaction with services. Ethics approval was provided by the Swedish Ethical Review Authority. Results A total of 2925 surveys were returned reflecting a response rate of 41%. Mean OPUS-CSS point score was 61.9(SD 16.8) with differences observed between device categories (p < 0.001). Factors that were identified as most positively influencing client satisfaction were, being a limb prosthesis user and being under 65 years. When analysing scores for individual OPUS items breast prosthesis users scored higher than users of other devices. Clients were most satisfied with the level of respect they were shown by staff (mean = 2.72/3) and less satisfied with coordination of services with other therapists/doctors(mean = 1.88/3). Conclusions Prosthetic and orthotic users are reasonably satisfied with the services they receive. Attention should be directed towards understanding why prosthetic users are more satisfied than orthotic users and why clients under 65 years report higher satisfaction scores.

BioMEL: a translational research biobank of melanocytic lesions and melanoma

IntroductionDiagnosing invasive cutaneous melanoma (CM) can be challenging due to subjectivity in distinguishing equivocal nevi, melanoma in situ and thin CMs. The underlying molecular mechanisms of progression from nevus to...

Elective one-minute full brain multi-contrast MRI versus brain CT in pediatric patients: a prospective feasibility study

BackgroundBrain CT can be used to evaluate pediatric patients with suspicion of cerebral pathology when anesthetic and MRI resources are scarce. This study aimed to assess if pediatric patients referred for an elective brain CT could endure a diagnostic fast brain MRI without general anesthesia using a one-minute multi-contrast EPI-based sequence (EPIMix) with comparable diagnostic performance.MethodsPediatric patients referred for an elective brain CT between March 2019 and March 2020 were prospectively included and underwent EPIMix without general anesthesia in addition to CT. Three readers (R1–3) independently evaluated EPIMix and CT images on two separate occasions. The two main study outcomes were the tolerance to undergo an EPIMix scan without general anesthesia and its performance to classify a scan as normal or abnormal. Secondary outcomes were assessment of disease category, incidental findings, diagnostic image quality, diagnostic confidence, and image artifacts. Further, a side-by-side evaluation of EPIMix and CT was performed. The signal-to-noise ratio (SNR) was calculated for EPIMix on T1-weighted, T2-weighted, and ADC images. Descriptive statistics, Fisher’s exact test, and Chi-squared test were used to compare the two imaging modalities.ResultsEPIMix was well tolerated by all included patients (n = 15) aged 5–16 (mean 11, SD 3) years old. Thirteen cases on EPIMix and twelve cases on CT were classified as normal by all readers (R1–3), while two cases on EPIMix and three cases on CT were classified as abnormal by one reader (R1), (R1–3, p = 1.00). There was no evidence of a difference in diagnostic confidence, image quality, or the presence of motion artifacts between EPIMix and CT (R1–3, p ≥ 0.10). Side-by-side evaluation (R2 + R4 + R5) reviewed all scans as lacking significant pathological findings on EPIMix and CT images.ConclusionsFull brain MRI-based EPIMix sequence was well tolerated without general anesthesia with a diagnostic performance comparable to CT in elective pediatric patients.Trial registrationThis study was approved by the Swedish Ethical Review Authority (ethical approval number/ID Ethical approval 2017/2424-31/1). This study was a clinical trial study, with study protocol published at ClinicalTrials.gov with Trial registration number NCT03847051, date of registration 18/02/2019.

Perpetuating ability to live life as usual: a grounded theory study of persons living with age-related macular degeneration

BackgroundAge-Related Macular Degeneration (AMD) is an eye disease associated with age that causes progressive and irreversible loss of central vision, while the peripheral visual ability remains. The occurrence of and especially late AMD is estimated to increase extensively to 2040 among persons aged ≥ 65 in Scandinavia, due to an increasing aging population.ObjectivesThe present study explored what it means to live with AMD through the eyes of those living with the condition.MethodsThis is an explorative interview study. People who were ≥ 65 years old, living in their own homes, and diagnosed with advanced dry AMD in one or both eyes, causing a visual acuity of no more than 0.3 or worse in the best eye, were invited to participate in the study. The method chosen was the constructivist grounded theory, where reality is seen as fundamentally social and processual and a way of accessing the participants’ experiences, thoughts, and feelings.ResultsIn total, 12 interviews were conducted. Living with dry AMD confronted different problems and challenges. The substantive theory, Perpetuating ability to live life as usual, is characterised by a desire to continue life as usual, which requires an acceptance of the disease’s progress, self-acceptance of the new me, and an acceptance that the new life needs to be lived a little more carefully. Moreover, the participants used three strategies to resolve their main concern by maintaining an everyday life 1) Navigating the new normal, 2) Trusting own ability, and 3) Interdepending.ConclusionMaintaining an everyday life is the primary concern among people with AMD. In supporting self-care, gaining information about the subjective experience to support their everyday living is of the utmost importance. This grounded theory captures valuable knowledge of how the older adults resolved their main concern “you got to keep on” despite their affected vision by “facing the fact” live life as usual since since life goes on. Our study also gives rise both to implications for research and practice in order to strengthen older people with AMD facing their future challenges.Trial registrationThe Swedish Ethical Review Authority (EPN 2021/02877).

Macro- and microscopic changes in veins with short-term central venous catheters: an observational autopsy study

BackgroundCentrally inserted central catheters (CICCs) are indispensable in modern healthcare, but unfortunately, come with complications. Catheter-related thrombosis is a well-known complication reported to occur in 5–30% of patients with CICC. There is a paucity of studies that report the incidence of catheter-related thrombosis after the introduction of real-time ultrasound insertion guidance as clinical practice. This study aimed to demonstrate any pathological macro- or microscopic changes in the vein wall associated with CICCs.MethodsThe study was approved by the Swedish Ethical Review Authority and was conducted at a large university hospital. The study included 12 patients with a short-term CICC who were subject to autopsies. Vessels with inserted catheters were macroscopically and microscopically examined.ResultsIn total, seven female and five male patients with a median age of 70 (interquartile range 63–76) were included. With one exception, all patients received routine thromboprophylaxis throughout the period with CICC. Most inserted CICCs were 9.5 French (54%) and were inserted in the internal jugular vein (92%). The median time with CICC was seven days (interquartile range 1.8–20). At autopsy, thrombi were observed in all cases (100%), macroscopically and microscopically, attached to the distal portion of the CICC and/or the adjacent vessel wall. Inflammatory changes in the vessel walls were seen in all cases, and varying degrees of fibrosis were demonstrated in eight cases (67%).ConclusionsThis autopsy study demonstrated that catheter-related thrombus formation with adjacent inflammatory and fibrotic vessel wall thickening was very common, despite a limited period of catheter use. The consequences of these findings are important, as thrombi may cause pulmonary embolism and possibly lead to catheter-related infections, and since inflammatory and fibrotic vessel wall thickening may evolve into chronic venous stenosis. Furthermore, the findings are a cause of concern, as CICCs are indispensable in modern healthcare and complications may be masked by the general disease that was the indication for CICC insertion.

The Effectiveness of Mindfulness Training on Self-Control and Social Adaptation in Housewives

Objective: The purpose of this study was to investigate the effectiveness of mindfulness training on self-control and social adaptation in housewives. Methods and Materials: The research method was a quasi-experimental design using a randomized two-group pretest-posttest approach. The statistical population of the study comprised all housewives visiting Fateh Garden in the Jahanshahr neighborhood of Karaj in 2023. Considering that the minimum sample size for a quasi-experimental design is 30 participants, housewives who exercised at Fateh Garden during the week, met the research criteria, and were willing to participate after receiving explanations about the procedures and ethical assurances from the researchers, were selected. A total sample size of 30 participants (15 in the experimental group and 15 in the control group) was chosen using a voluntary sampling method and randomly assigned to the two groups. Data were collected using the Bell Social Adaptation Scale, the Tangney Self-Control Scale, and sessions based on the mindfulness training by Lewas and Schumann Oliver (2018). Findings: Results indicated that mindfulness training had a positive and significant impact on self-control and social adaptation in housewives. Conclusion: Thus, the potential of mindfulness training to enhance aspects such as self-control and social adaptation in couples can be utilized.