Regional Research Ethics Committee Research Articles

Study protocol for assessment of the efficacy of calcium dobesilate versus placebo on SARS-CoV-2 viral load in outpatients with COVID-19 (CADOVID study): a randomised, placebo-controlled, double-blind, monocentric phase II trial

IntroductionSARS-CoV-2 mainly infects respiratory endothelial cells, which is facilitated through its spike protein binding to heparan sulphate. Calcium dobesilate (CaD) is a well-established, widely available vasoactive and angioprotective drug interacting...

Consensus statements on the utility of defining ARDS and the utility of past and current definitions of ARDS—protocol for a Delphi study

IntroductionAcute respiratory distress syndrome (ARDS), marked by acute hypoxemia and bilateral pulmonary infiltrates, has been defined in multiple ways since its first description. This Delphi study aims to collect global...

Urban environment and health: a cross-sectional multiregional project based on population health surveys in Spain (DAS-EP project) – study protocol

IntroductionThe European Environment Agency estimates that 75% of the European population lives in cities. Despite the many advantages of city life, the risks and challenges to health arising from urbanisation...

Protocol for a randomised controlled trial comparing warfarin with no oral anticoagulation in patients with atrial fibrillation on chronic dialysis: the Danish Warfarin-Dialysis (DANWARD) trial

IntroductionAtrial fibrillation is highly prevalent in patients on chronic dialysis. It is unclear whether anticoagulant therapy for stroke prevention is beneficial in these patients. Vitamin K-antagonists (VKA) remain the predominant...

Stretching oneself too thin and facing ethical challenges: Healthcare professionals' experiences during the COVID-19 pandemic.

Most countries are facing increased pressure on healthcare resources. A better understanding of how healthcare providers respond to new demands is relevant for future pandemics and other crises. This study aimed to explore what nurses and doctors in Norway reported as their main ethical challenges during two periods of the COVID-19 pandemic: February 2021 and February 2022. A longitudinal repeated cross-sectional study was conducted in the Western health region of Norway. The survey included an open-ended question about ethical challenges among doctors and nurses in hospital departments. Free-text comments were analysed using Systematic Text Condensation and also presented in a frequency table. Ethical approval was granted by the Regional Research Ethics Committee in Western Norway (131,421). All participants provided consent when participating in the study. In 2021, 249 and in 2022, 163 healthcare professionals responded to the open-ended question. Nurses and doctors reported three main categories of ethical challenges related to the COVID-19 pandemic: (1) barriers that hindered them in acting as they ethically would have wanted to do; (2) priority-setting dilemmas linked to overtreatment, transfer of resources and ranking patient needs; and (3) workload expansion threatening work-life balance and employees' health. Category one comprised of resource barriers, regulatory barriers, system barriers, and personal barriers. Regulatory barriers, especially visitor restrictions for next-of-kin, were the most frequently reported in 2021. Resource barriers, related to the increased scarcity of qualified staff, were most frequently reported in 2022. Clinicians stretched themselves thin to avoid compromising on care, diagnostics, or treatment. Developing clinicians' ability to handle and cope with limited healthcare resources is necessary. To foster resilience and sustainability, healthcare leaders, in collaboration with their staff, should ensure fair priority-setting and initiate reflections among doctors and nurses on what it implies to provide 'good enough' care.

Knowledge and information sources of potential drug–drug interactions of healthcare professionals among Buraydah Hospitals

Background and objectiveDrug–drug interactions (DDI) are known to increase the risk of morbidity and mortality, and adversely affect the patient's quality of life. The study was to assess healthcare professional's (HCP) knowledge of DDIs in general hospitals of Buraydah.MethodsA cross-sectional survey using convenience sampling methods was conducted among 135 healthcare professionals in general hospitals of Buraydah between November and December 2016. The study was carried out after approval and permission from the Regional Research Ethics Committee (November 2016). Respondents were asked to classify 15 drug pairs as 'contraindicated', 'could be used with monitoring', or 'no interaction'. A response option of 'not sure' was also provided. Data were collected using a self-administered questionnaire. The descriptive analysis was done using frequency distribution and percentage for demographic data and other responses to questions. Data were collected, tabulated, and analyzed using Statistical Package for Social Sciences (SPSS) software (version 23). Logistic regression analysis was used to assess the independent variables that affect the HCP knowledge, the significant levels were set at p-value < 0.05.ResultsA total of 135 healthcare professionals were included in the study. The percentage of HCPs who correctly classified the drug pairs ranged from 15 (11.1%) for "Allopurinol + Pyrazinamide" to 90 (66.7%) for "acetaminophen with codeine + amoxicillin". The average number of correctly categorized drug pairs was 5. About one-half of the respondents 73 (54.1%) answered correctly. The level of education was found to be an independent predictor of DDI knowledge. The results from the multivariate analysis indicated that a higher potential DDI knowledge level was associated with pharmacists. Pharmacists had 8.27 times higher DDI knowledge tests than nurses, P value = 0.001. Pharmacists 43(31.9%) were the most cited information source.ConclusionsThe present study revealed that health care professional’s DDI knowledge was inadequate. Level of education was significantly associated with healthcare professionals’ DDI knowledge. Pharmacists were the most cited DDI information source. Healthcare professionals should update their DDI knowledge through continuing education and should improve their familiarity with DDI information sources. These updated educations help to provide the appropriate therapeutic outcomes.

ITV-Pal programme: protocol of evaluation of the implementation of tech-volunteer programme in palliative care services

IntroductionVolunteer support for patients and families at the end of life provides many benefits for the beneficiaries. New technologies could be a necessary resource in the accompaniment although, if there...

Comparison of Graft Survival in Kidney Transplant Recipients Over 50 Years and Under 50 Years in Tabriz Imam Reza Hospital

&lt;span class="correspondence-author"&gt;Introduction&lt;/span&gt; Chronic kidney failure is one of the most common diseases in the world. The prevalence and incidence of end-stage renal disease are increasing in developed and developing countries, bringing a tremendous financial burden to healthcare systems. Therefore, according to the above, this study aims to compare graft survival in kidney transplant recipients over 50 years old and under 50 years old in Imam Reza Hospital, Tabriz, Iran. &lt;span class="correspondence-author"&gt;Methods&lt;/span&gt; Following approval from the Regional Research Ethics Committee, a retrospective study was conducted on all patients admitted to Imam Reza Hospital in Tabriz in 2020 who underwent kidney transplantation. &lt;span class="correspondence-author"&gt;Results&lt;/span&gt; This study included 74 patients, of which 50 (67.6%) were male, and 24 (32.4%) were female. The mean age of the transplant recipients was 40.91 ± 14.20, with 47 (63.5%) being under 50 years of age and 27 (36.5%) aged 50 or above. Of these patients, 8 (10.8%) were deceased, and 66 (89.2%) were living cases. The left kidney was transplanted in 67 (90.5%) and the right kidney in 7 (9.5%). The mean age of the deceased patients (8 patients) was 53.37 ± 9.73, while the mean age of the living patients (66 patients) was 39.40 ± 13.96, resulting in a statistically significant difference (p &amp;lt; 0.01). Additionally, 6 (22.2%) of the patients aged 50 and above who underwent transplantation died, compared to 4.3% in the patients aged under 50 (2 patients); this was also statistically significant (p = 0.01). &lt;span class="correspondence-author"&gt;Conclusion&lt;/span&gt; The results of the study, which involved 74 patients, revealed that there was no significant difference in gender and side of the transplanted kidney between the two groups; however, age was found to be an important factor in patient survival.

Women’s experiences of continuity of care from student midwives – A qualitative study from Norway

ObjectiveThe study aimed to gain a deeper understanding of women's experience of continuity of care by student midwives during the childbearing process. MethodA qualitative approach was the design used in this study. In-depth interviews were conducted with nine women who had received continuity of care during their childbearing process by student midwives. The interviews were analysed with the help of systematic text condensation. The study was approved by the Norwegian Centre for Research Data (ref. 905085) and the Regional Research Ethics Committee (ref. 2019/608). FindingsContinuity of care enabled a deep relationship between the woman and the student midwife and made the care provided more individualised, giving the woman emotional support and preparing her for birth. The presence of a student midwife during labour and birth who knew the woman’s story made the woman able to focus on the birth process. Even when unexpected events occurred, the woman had a positive birth experience due to the relationship between her and the student midwife. Continuity of care made the women feel safe and taken care of and was the preferred model of care. ConclusionContinuity of care contributes to individualised and personalised care, enabling all aspects of the woman's needs to be considered throughout the childbearing process. Due to the positive impact on the women in the present study, it is appropriate to implement a continuity of care model in midwifery education programmes. Further research should be conducted to examine how doing so would influence both student midwives and women.

Effects of ATLAS 2030 gait exoskeleton on strength and range of motion in children with spinal muscular atrophy II: a case series

BackgroundChildren with spinal muscular atrophy (SMA) present muscle weakness and atrophy that results in a number of complications affecting their mobility, hindering their independence and the development of activities of daily living. Walking has well-recognized physiological and functional benefits. The ATLAS 2030 exoskeleton is a paediatric device that allows gait rehabilitation in children with either neurological or neuromuscular pathologies with gait disorders. The purpose is to assess the effects in range of motion (ROM) and maximal isometric strength in hips, knees and ankles of children with SMA type II after the use of ATLAS 2030 exoskeleton.MethodsThree children (mean age 5.7 ± 0.6) received nine sessions bi-weekly of 60 min with ATLAS 2030. ROM was assessed by goniometry and strength by hand-held dynamometer. All modes of use of the exoskeleton were tested: stand up and sit down, forward and backward walking, and gait in automatic and active-assisted modes. In addition, different activities were performed during the gait session. A descriptive analysis of all variables was carried out.ResultsThe average time of use was 53.5 ± 12.0 min in all sessions, and all participants were able to carry out all the proposed activities as well as to complete the study. Regarding isometric strength, all the measurements increased compared to the initial state, obtaining the greatest improvements for the hip flexors (60.2%) and extensors muscles (48.0%). The ROM increased 12.6% in hip and 34.1% in the ankle after the study, while knee ROM remained stable after the study.ConclusionImprovements were showed in ROM and maximal isometric strength in hips, knees and ankles after using ATLAS 2030 paediatric gait exoskeleton in all three children. This research could serve as a preliminary support for future clinical integration of ATLAS 2030 as a part of a long-term rehabilitation of children with SMA.Trial registration: The approval was obtained (reference 47/370329.9/19) by Comunidad de Madrid Regional Research Ethics Committee with Medical Products and the clinical trial has been registered on Clinical Trials.gov: NCT04837157.

Developing a medication adherence technologies repository: proposed structure and protocol for an online real-time Delphi study

IntroductionAn online interactive repository of available medication adherence technologies may facilitate their selection and adoption by different stakeholders. Developing a repository is among the main objectives of the European Network...

Prognostic stratification of older patients with multivessel coronary artery disease treated with percutaneous transluminal coronary angioplasty based on clinical and biochemical measures: protocol for a prospective cohort study

IntroductionThe incidence of acute coronary syndrome is rising in step with the growth of life expectancy. An increase in the age of patients with coronary artery disease has been related...

Evaluation of the "partnership care model" on quality of life and activity of daily living in stroke patients: A randomized clinical trial.

Stroke is a widespread chronic disease which remains a serious problem for public health and is the cause of major disability and death in adults. Despite valuable efforts, these patients still need new care programs for recovery and rehabilitation. The aim of this study is to determine the effect of the partnership care model (PCM) on quality of life (QOL) and activities of daily living (ADL) in stroke participants. The study is a randomized clinical trial carried out in an educational and therapeutic center in 2019. Sixty-seven participants (allocated randomly in intervention and control groups) with cerebrovascular accident who had hospitalization histories were selected. Data collection instruments were the Stroke-Specific QOL scale and Lawton questionnaires. The care plan was developed and implemented for the intervention group after evaluating and recording basic information including demographic variables, care needs, and problems identified in the first PCM-based stage. Ethics approval was obtained from the University / Regional Research Ethics Committee (IR.NIMAD.REC.1397.236). The results show that the mean scores of the QOL significantly increased after the intervention in the intervention group (before=130.80; 3months=172.19; 6months=205.29) compared to the control group (before=150; 3months=144.86; 6months=160.66). Also, the mean scores of the ADL significantly increased after the intervention in the intervention group (before=1.96; 3months=3.64; 6months=4.87) compared to the control group (p< .05). The effect size is equal to 0.501 and 0.245 for QOL and ADL, respectively. The findings show that the care program based on a PCM recovered the QOL and ADL of stroke participants more than other interventions.

Intensive group-based cognitive therapy in patients with cardiac disease and psychological distress\u2014a randomized controlled trial protocol

BackgroundMany patients with coronary artery disease (CAD) and valvular heart disease (VHD) suffer from psychological distress. Such stress is associated with increased morbidity, reduced quality of life and delayed return to work. European guidelines emphasize recognition and intervention, but evidence-based treatment options are limited and perceived as costly. The present study will test the effect of brief, group-based cognitive therapy as an adjunct to usual cardiac rehabilitation in a randomized design.MethodsA total of 148 patients with CAD and/or VHD after surgical intervention and concomitant psychological distress (defined as HADS anxiety (A) or depression (D) score ≥8) will be randomized to either usual out-patient cardiac rehabilitation (CR) comprising an 8-week multidisciplinary programme or usual care supplemented by five group-based cognitive therapy sessions performed by trained CR nurses. A structured, standardized treatment manual will be used. Patients will be randomized 1:1 at three different sites. Additionally, a non-randomized sub-group of 40 matched patients without signs of psychological distress will be followed to investigate spontaneous variation in HADS. The primary outcome is Hospital Anxiety and Depression Score (HADS). Secondary outcomes are adherence to cardiac rehabilitation (CR), health-related quality of life measured by HeartQoL, time to return to work, adherence to lifestyle interventions and cardiovascular readmissions. Patients are followed up for 12 months.DiscussionTo our knowledge, this is the first randomized controlled trial (RCT) on patients with cardiac disease with an intensive group-based programme of cognitive therapy performed by CR nurses, which makes it affordable and widely implementable. The outcome will elucidate the feasibility and effect of cognitive therapy as an adjunct to CR in patients with post-surgery CAD and/or VHD and psychological distress and could possibly benefit patients with other heart conditions as well. The clinical trial complies with the Declaration of Helsinki. The trial has been approved by The Regional Research Ethics Committee (file number H-16042832) and The Danish Data Protection Agency. The results will be disseminated as original research in peer-reviewed manuscripts.Trial registrationwww.clinicaltrials.govNCT04254315. Retrospectively registered on 30 January 2020.

Priority-setting dilemmas, moral distress and support experienced by nurses and physicians in the early phase of the COVID-19 pandemic in Norway

Background:The global COVID-19 pandemic has imposed challenges on healthcare systems and professionals worldwide and introduced a ´maelstrom´ of ethical dilemmas. How ethically demanding situations are handled affects employees’ moral stress and job satisfaction.Aim:Describe priority-setting dilemmas, moral distress and support experienced by nurses and physicians across medical specialties in the early phase of the COVID-19 pandemic in Western Norway.Research design:A cross-sectional hospital-based survey was conducted from 23 April to 11 May 2020.Ethical considerations:Ethical approval granted by the Regional Research Ethics Committee in Western Norway (131421).Findings:Among the 1606 respondents, 67% had experienced priority-setting dilemmas the previous two weeks. Healthcare workers who were directly involved in COVID-19 care, were redeployed or worked in psychiatry/addiction medicine experienced it more often. Although 59% of the respondents had seen adverse consequences due to resource scarcity, severe consequences were rare. Moral distress levels were generally low (2.9 on a 0–10 scale), but higher in selected groups (redeployed, managers and working in psychiatry/addiction medicine). Backing from existing collegial and managerial structures and routines, such as discussions with colleagues and receiving updates and information from managers that listened and acted upon feedback, were found more helpful than external support mechanisms. Priority-setting guidelines were also helpful.Discussion:By including all medical specialties, nurses and physicians, and various institutions, the study provides information on how the COVID-19 mitigation also influenced those not directly involved in the COVID-19 treatment of patients. In the next stages of the pandemic response, support for healthcare professionals directly involved in outbreak-affected patients, those redeployed or those most impacted by mitigation strategies must be a priority.Conclusion:Empirical research of healthcare workers experiences under a pandemic are important to identify groups at risks and useful support mechanisms.

Clinical Characteristics of COVID-19 Patients in a Regional Population with Diabetes Mellitus: The ACCREDIT Study

Background: It is known that diabetes is associated with greater COVID-19 mortality. However, what remains unclear is whether characteristics specific to this cohort contribute to the prognosis of COVID-19. We identified clinical and biochemical characteristics associated with mortality and the need for intensive care amongst an inpatient population with diabetes and COVID-19.Methods: We conducted a retrospective cohort study across the North West Merseyside region assessing clinical and biochemical characteristics associated with 7-day, 30-day mortality, and ITU admission as primary outcomes. All patients with diabetes infected with COVID-19 admitted to 7 hospitals within the region from 1 January to 30 June 2020 were included and data collected directly from medical notes by clinicians managing the condition. We calculated the inpatient mortality rates for this cohort. Statistical analyses included multivariate logistic regression to examine the effect of the aforementioned characteristics on the primary outcome. We also performed a series of Kaplan-Meier curves to assess the mortality rate trend over time.Findings: This study analysed 1004 hospitalised patients with diabetes with COVID-19. Mean age was 74.1 (± 12.6) years. They were predominantly men (60.7%). 45% belonged to the two most deprived deciles in the UK. Median BMI was 27.6 (IQR 23.9-32.4) kg/m2. Most had a diagnosis of T2DM (94.8%) and the mean HbA1c was 61.2 ± 19.7 mmol/mol (7.7 ± 4%). Microvascular and macrovascular complications of diabetes were evident in 49.6% and 56.2% respectively. The primary outcome of death by day 7 was observed in 24%, which increased to 33% by day 30. In univariate analysis, characteristics associated with the primary outcome were age and CRP (pInterpretation: The results of this regional analysis of persons with diabetes infected with COVID-19 showed that CRP and age were associated and predictive for in-hospital death by day 7.Funding: None.Conflict of Interest: NoneEthical Approval: The study was approved by the Regional Research ethics committee.

Involving High-Grade Glioma Patients and Their Carers in Qualitative Research to Promote Structured Physical Activity: A Mixed-Methods Study Protocol

Introduction: Structured physical activity may improve physical, cognitive, and social functionality, as well as overall quality of life of people with high-grade glioma. Yet, engaging them in such activities remains highly challenging due to their unique disease burden and perceived “loss of control.” A greater understanding of patients’ interests, preferences, behavioral motivations, and perceived barriers around physical activity is needed to design tailored and patient-led physical activity interventions. This protocol describes the method and ethical considerations of a cross-sectional mixed-methods study that has been developed to collect such information from glioma patients and their carers. Methods and analysis: The International Physical Activity Questionnaire (IPAQ 7, short form) and semi-structured interviews will be used for data collection. IPAQ scoring protocol will be followed to examine objective data and Clarke and Braun’s thematic approach will be used to analyze the interview transcripts. Ethics: Ethical approval was obtained from Cardiff University’s Research Ethics Committee and from the regional NHS Research Ethics Committee. The main ethical concerns are to maintain patients’ safety and comfort and ensure that their consent remains informed and valid throughout the recruitment, data collection, management, and dissemination stage. Risks associated with their physical condition, emotional distress, and time commitment should be continuously assessed and necessary actions should be taken accordingly. Conclusion: The protocol will work as a step by step guide for future researchers for developing similar qualitative research and obtaining ethical approval when involving vulnerable individuals like high-grade glioma patients in studies.

Effect Of Melatonin On The Efficacy Of Chloralhydrate In Sedating Children Undergoing Auditory Brainstem Response Test.

ABSTRACT: Background: To obtain an accurate diagnosis, children with hearing impairment could be examined by auditory brainstem response test. Young children are usually uncooperative and could not be examined without sedation. The most commonly used sedative is chloral hydrate. Some investigators used melatonin as an alternative sedative. Our study aimed to evaluate the effect of melatonin as adjuvant when added to chloral hydrate. Methods: The study was conducted at the Clinic for Hearing, Balance and Communication, Mosul, Iraq, from July to December 2018, and has been approved by the regional Research Ethics Committee with a design of the un-blinded randomized clinical trial. Parents provided a written informed consent. Two hundred and fifty-four children aged 8 months-7 years attending for auditory brainstem response test were allocated randomly to two groups. The group A children as controls (n=150), were receiving chloral hydrate oral dose 50mg/kg, while the group B cases (n=104), were receiving melatonin 0.1mg/kg plus chloral hydrate 50mg/kg. Both groups were compared in sleep latency, success rate of sedation within 30 minutes, as well as sleep duration. Relative risk (RR), t-test and chi-square were used. Results: Within 30 minutes of the initial dose intake, the group of the combined melatonin and chloral hydrate achieved a higher success rate in the sleep induction than the group of the chloral hydrate, (n=98, 94.2% versus n=112, 74.6%), RR=1.262, P<0. 001.Conclusion: Melatonin could enhance the efficacy of chloral hydrate when added to it, as an adjuvant agent.

Cognitive impairment and psychopathology in out-of-hospital cardiac arrest survivors in Denmark: The REVIVAL cohort study protocol

IntroductionCognitive impairment and psychopathology caused by brain hypoxia and the traumatic impact of critical illness are common in cardiac arrest survivors and can lead to negative consequences of everyday life...

Consequences of Early Career Nurse Burnout: A Prospective Long-Term Follow-Up on Cognitive Functions, Depressive Symptoms, and Insomnia

Background: Burnout is common among nurses and midwifes. We examined whether an early career episode of burnout has long-term consequences on; a) cognitive functions, b) symptoms of depression, and/or c) insomnia for nurses a decade after graduation. Methods: Symptoms of burnout were investigated in an observational longitudinal study of three national cohorts of registered nurses (RNs). Nursing students were recruited from all 26 of Sweden’s nursing programs. Burnout was subsequently measured through annual assessment over the first three years post graduation, with one long-term follow-up 11-15 years after graduation. A total of 2472 nurses (62%) consented to participate at follow-up. Burnout was measured using the Oldenburg Burnout Inventory, cognitive function by a study specific instrument, depressive symptoms by the Major Depression Inventory, and sleep problems using items from the Karolinska Sleep Questionnaire. We used multivariable logistic regression to identify factors associated with consequences of early career burnout, adjusting for concurrent levels at follow up. Findings: The prevalence of nurses reporting high levels of burnout symptoms at least one of the first three years of working life was 299 (12·3%). High levels of burnout symptoms in early working life were significantly related to more frequent symptoms of cognitive dysfunction, depression, and impaired sleep a decade later when taking current burnout levels into account. After controlling for both current symptoms of burnout and the other outcome variables, nurses with early career burnout still reported more frequent problems with cognitive functions and sleep but not depression. Interpretation: The results of this study show that the detrimental processes caused by overwhelming or chronic stress start early on in nurses’ careers and thus preventive efforts should preferably be introduced early on (e.g. as part of nursing education and onboarding programs). Funding: AFA Insurance Grant [number 150284]. Declaration of Interests: All authors report no competing interests. Ethics Approval Statement: Ethical permission was given by the Regional Research Ethics Committee at Karolinska Institutet, Stockholm, Sweden (Dnr 01-045), and the Regional Ethics Review Board in Stockholm, Sweden (Dnr 04-587 and for the long-term follow-up Dnr 2016 / 793-32).