Clinical Ethics Committee Research Articles

Encountering uncertainty and complexity in decision-making: an observational study of clinical reasoning among medical and interprofessional groups of health care students

ABSTRACT Poor teamwork and clinical decisions have a major impact on patient outcomes and safety. Clinical decision-making rarely occurs under ideal conditions, but complex health care environments make this particularly challenging for new graduate health professionals as beginner practitioners. Recent evidence indicates that effective collaboration also enhances quality of clinical decisions for patients with complex needs. However, collaborative decision-making is not standard in educational curricula, where clinical decision-making is usually taught in profession-specific courses emphasizing individual rationality and cognition. The aim of this study was to gain detailed insights into the practice of clinical decision-making by small groups of medical and other health care students. A qualitative observational study design was used. Students (n = 45) took part in a short role-play of a hospital clinical ethics committee meeting discussing three complex patient cases, considering clinical and ethical aspects of care, and made a group decision about priorities for treatment. Audio-recorded data were transcribed verbatim and inductively analyzed based on Strauss’s “Theoretical Coding” approach. Coding and interpretation of transcripts resulted in three key themes: a) values/beliefs as a basis for negotiation; b) encountering obstacles; c) overcoming obstacles. All groups benefited from shared knowledge, assisting each other in dealing with uncertainty and perceived emotional burden. In small groups, they were able to overcome challenges and fulfil a goal potentially beyond many of them as individuals. Provision of learning opportunities where students learn to share expertise and decision-making responsibilities has the potential to optimize their learning in preparation for challenges in future practice.

Psychometric evaluation of the Ethical Caring Competency Scale in nursing

BackgroundAn ethical competence list for nurses could guide educators and managers in the field of health care to both support the development of ethical conduct and improve the assessment of ethical competence in health care.AimThis study aimed to verify the reliability and validity of the Ethical Caring Competency Scale (ECCS) and to obtain suggestions for its use as an evaluation form in rubric format among a sample of Japanese nurses.Research designThis research employed a descriptive and cross-sectional design.Participants and research contextA self-administered questionnaire was distributed to 1157 nurses working in two hospitals in Japan. The contents of the survey were demographic data, a draft of the ECCS consisting of 22 competencies from four core competencies, questions regarding experience in learning about medical/nursing ethics, and the Work Motivation Measurement Scale for Nurses. Three levels of difficulty for the 22 items were established using relative comparisons of the mean scores within the four core competencies. Three groups, namely, an expert group, a middle group, and a beginner group, were categorized according to the quartiles of the total ECCS score.Ethical considerationsThis study was approved by the Clinical Research Ethics Committee of Hamamatsu University School of Medicine (Decision no. 18-267). The ethical principles of voluntary participation, anonymity, and confidentiality were considered.FindingsA total of 962 valid responses were analyzed. The ECCS scores for the three levels of difficulty were significantly different from each other. Stability was confirmed by the test-retest of the total ECCS scores (r = .900, p < .0001). The total ECCS scores for the three groups showed significant differences in all pairs. The Cronbach’s α coefficient ranged from .72 to .89 for each core competency, and internal consistency was confirmed.ConclusionThe reliability and validity of the ECCS as a scale were statistically verified, and we were able to obtain suggestions for its application as a form of evaluation in rubric format.

Development and validation of a clinical diagnostic model for pregnant women with renal colic in the emergency department in China: a protocol for a retrospective cohort study

IntroductionUrolithiasis affects many people throughout their lives. Among the maternal population, although the morbidity of acute urolithiasis in pregnant women is unremarkable, it is the leading cause of hospitalisation during...

Efficacy and safety of endovenous microwave ablation versus laser ablation for great saphenous vein varicosis: study protocol for a multicentre, randomised controlled non-inferiority trial

IntroductionEndovenous microwave ablation (EMA) is a relatively novel thermal ablation treatment for great saphenous vein (GSV) varicosis, and its efficacy and safety are rarely reported. This study aims to explore...

Efficacy of INtensive Treatment vs. Standard Treatment of COmpound DanshEn Dripping Pills in Refractory Angina Patients With Incomplete Revascularization (INCODER Study): Study Protocol for a Multicenter, Double-Blind, Randomized Controlled, Superiority Trial.

IntroductionPatients with incomplete revascularization (ICR) tend to develop refractory angina despite optimal medical therapy. The Compound Danshen Dripping Pills (CDDP) is a widely used antianginal drug in China and is shown to significantly alleviate myocardial ischemia. Previous studies showed dose-efficacy tendency when increasing doses of CDDP. This study aims to investigate the efficacy and safety of intensive doses of CDDP in patients with refractory angina with ICR.Methods and AnalysisThe INCODER study is a multicenter, double-blind, randomized controlled, superiority trial. We plan to recruit 250 patients aged 18–85 years with a diagnosis of refractory angina with ICR. Patients will be randomized (1:1) to intensive treatment group (CDDP 20 pills three times per day) or standard treatment group (10 pills CDDP and 10 pills placebo three times per day). Patients will have a 6-week medication period and be followed up every 2 weeks. The primary endpoint is the change of total exercise time from baseline to week 6 as assessed by cardiopulmonary exercise testing (CPET). Secondary endpoints include changes in the frequency of angina, Canadian Cardiovascular Society angina class, nitroglycerin use, Seattle Angina Questionnaire scores, peak oxygen uptake (VO2 peak) and other parameters as measured by CPET, and the levels of plasma C-reactive protein, homocysteine, and N-terminal pro-B-type natriuretic peptide. Safety events related to CDDP use will be monitored.Ethics and DisseminationThe research had been approved by the Clinical research and laboratory animal ethics committee of the First Affiliated Hospital, Sun Yat-sen University ([2019]65). The results will be reported through peer-reviewed journals, seminars, and conference presentations.Trial Registration Numberwww.chictr.org.cn (ChiCTR2000032384). Registered on 27 April 2020.

Why Non-Clinicians Should Not Be Doing Clinical Ethics

Why Non-Clinicians Should Not Be Doing Clinical Ethics

Determination of the healthcare satisfaction of the parents staying in the hospital with their children diagnosed COVID-19 towards family-centered care

To determine the healthcare satisfaction of the parents staying in the hospital with their children diagnosed Covid-19 towards family-centered care and to determine the relationship between them. This was a descriptive, correlational and cross-sectional type study. Data were collected in a pediatric outpatient clinic of a university hospital between March-June 2021. The universe of the study consisted of 141 parents, and the calculated sample size was 59. The study was completed with 64 parents. Data of the study were collected in the light of literature by using Sociodemographic Information Form, The Family-Centered Care Scale and The Pediatric Quality of Life Healthcare Satisfaction Inventory. Data were analyzed by SPSS 21 statistical package program. The ethics approval was taken from the clinical research ethics committee of the relevant university. The mean score of the parents from the Family-Centered Care Scale was 60.58±8.77, the mean PedsQL Healthcare Satisfaction Inventory score of the parents was found to be 71.75±24.21. A positive and moderate level of correlation was found between the Family-Centered Care Scale and PedsQL Healthcare Satisfaction Inventory and their subscales. It was found that nurses helped families and children to feel well cared for; however, they did not get the opinions of the family at a sufficient level while planning care. In the study, the healthcare satisfaction of the parents was at an adequate level. Besides, it was determined that the opinions of parents regarding family-centered care positively affected their satisfaction.

Birinci basamakta çalışan aile hekimlerinin palyatif bakımla ilgili yaklaşımları

Introduction: Determining the awareness of family physicians working in primary care about palliative care, to determine their attitudes and behaviors towards patients and their relatives, and their approaches are aimed in this study.Methods: The universe of the cross-sectional and descriptive study consists of 194 family physicians in Tokat in January 2020. However 23 physicians who refuse to participate and 15 physicians who could not reached in detected dates were excluded from the study. 156 physicians were applied prepared questionnaire. The necessary permissions were obtained from the Provincial Health Directorate and the clinical research ethics committee. The data were evaluated with IBM Statistics 20.0 SPSS statistical software. Chi-square test was used to test the differences, and p &amp;lt;0.05 was accepted statistically significant.Results: Regarding participants 98 (62,8%)were male, 58 (37,2 %) female, mean age 40,5±9,8 and mean working years 15,8. 6.4% (n: 10) of the participants were family medicine specialists and 93.6% (n: 146) general practitioners. The proportion of respondents who state the correct answer as ‘palliative care deals with life-threatening diseases’ was 60.3%. The proportion of those who helped palliative care patients about nutrition was 29.5% (n: 46) and 60 physicians supported for psychiatric problems (38.5%). 51.3% of the physicians prescribed opioid group drugs. The rate of those who want to follow patients in the family health center as integrated with the palliative care units 20.5%, and this rate was found to be statistically significantly higher in female physicians (p: 0.03). 11.5% of the physicians received palliative care training, while 61.5% stated that they wanted to receive regular training in this regard.26.9 % of participants want to specialize in palliative care. 74.3% of physicians think that palliative care practices should not be included into performance system in the family medicine practices.Conclusions: In the current system, it was found that family physicians did not have sufficient training and equipment related to palliative care. In line with the increasing need for palliative care in primary care, some up-to-date arrangements and in-service trainings should be brought to the agenda.Keywords: Family practice, palliative care, pain, opioid analgesics, palliative care training

Analysis of a clinical ethics committee activities at a general hospital

Clinical Ethics Committees are deliberative groups whose main functions are to assess cases with ethical-clinical conflicts, to generate institutional protocols for preventive purposes, and to train health teams. To analyze the activity of a clinical ethics committee of a general hospital in the period 2007-2020. A retrospective analysis of all session records, annual reports, case resolution and documents generated by the Clinical Ethics Committee of Carlos van Buren Hospital in Valparaíso, Chile, between 2007 and 2020, was carried out. On average, 12 cases are analyzed per year. Sixty percent correspond to requests from pediatric units and in 78% of these cases there was at least one neurological disease. In 62% of cases, the main ethical dilemma was adequacy of therapeutic effort, followed by dilemmas related to the exercise of autonomy in 18.2%. In education, two courses are identified aimed to doctors, residents, and other members of the health team. Regarding normative functions, several documents were generated at the request of the Hospital management or in different clinical situations. During COVID-19 pandemia, the active role of the committee was linked to the three main functions, namely evaluating cases, participating in morbidity and mortality meetings for preventive purposes, and issuing guidelines and recommendations for action. The active participation of Pediatric Neurology residents in the Committee, for educational and administrative purposes, stands out. The three main functions described for the ethics committees were exerted by this Committee during the evaluated period. The impact of our recommendations remain to be objectively evaluated.

Ethical Design and Use of Robotic Care of the Elderly

The Australian Royal Commission into Aged Care Quality and Safety acknowledged understaffing and substandard care in residential aged care and home care services, and recommendations were made that that the Australian Government should promote assistive technology within aged care. Robotic care assistants can provide care and companionship for the elderly—both in their own homes and within health and aged care institutions. Although more research is required into their use, studies indicate benefits, including enabling the elderly to live independently at home, assistance with medication and monitoring of safety. Nevertheless, there are inherent ethical challenges in the use of robots as carers, including loss of privacy, unwarranted restrictions on autonomy, lack of dignity, deception, and the exacerbation of loneliness. Ethics by design can counter these issues in development of robotics and clinical ethics committees have been put forward as a way of dealing with the ethical use of robotic care in healthcare institutions. In this paper I outline the ethical challenges of robotic care assistants and how these may be mediated in their design and use.

Efficacy, safety and cost-effectiveness of methotrexate, adalimumab or their combination in non-infectious non-anterior uveitis: a protocol for a multicentre, randomised, parallel three arms, active-controlled, phase III open label with blinded outcome assessment study

IntroductionNon-infectious uveitis include a heterogeneous group of sight-threatening and incapacitating conditions. Their correct management sometimes requires the use of immunosuppressive drugs (ISDs), prescribed in monotherapy or in combination. Several observational...

Impact of Education on Student Nurses' Advocacy and Ethical Sensitivity.

The nursing literature emphasizes that there are still inadequacies, differences, and inconsistencies in the definition of nurses' advocacy role, and that nursing education plays an important role in educating nurses for patient advocacy. The aim of the present study is to determine the effects of advocacy education onsocial justice advocacy and ethical sensitivity. Pre-test, post-test, parallel group, randomized controlled study. The study was carried out on 80 undergraduate nursing students in Turkey. Students was divided into experimental (40) and control (40) groups. Experimental group received advocacy education cirruculum. Both groups were applied as Socio-Demographic Characteristics, as pre- test and post-tests Social Justice Advocacy Scale, and Moral Sensitivity Questionnaire. The data were statistically evaluated with, the chi-square test, Two-Way Anova. The study was approved by Selcuk University Faculty of Health Sciences Non-Interventional Clinical Research Ethics Committee (09.25.2019/1218). Written informed consent was obtained from all participants. The pre-test score of the intervention group and that of the control group were similar(p > 0.05). The study group's post-test score was significantly higher than its pre-test score and the post-test score of the control group "social justice advocacy skills" and "moral sensitivity Questionnaire." In two-way analysis of variance in repeated measures, there was a significant main effect of the type of groups. The two-way ANOVA results in repeated measures showed that group-time interaction was significant. The advocacy education cirruculum the experimental group increased in the social justice advocacy knowledge, attitude and skills and moral sensitivity. The advocacy education cirruculum the experimental group increased the social justice advocacy skills and moral sensitivity. The Advocacy education cirruculum can be suggested to be integrated into the undergraduate nursing curriculum.

Feasibility, effectiveness, and satisfaction achieved by the transdisciplinary intervention of a clinical-hospital ethics committee. A qualitative and quantitative study.

A clinical ethics committee (CEC) has educational, regulatory, advisory, mediation, and reflexive functions. As any health care service, the consults with the CEC should be subjected to review and quality improvement. The study objectives were to assess the feasibility, effectiveness, and satisfaction with the bioethical recommendations made by the CEC and assess their impact on the treating team and the patient's family. Descriptive, retrospective, qualitative, and quantitative study of clinical cases submitted to the hospital's CEC between January 1st, 2013 and December 31st, 2017 using data from the CEC minute book, medical records, registries from the Office for Remote Communication, and semi-structured interviews with health care team members. A total of 108 cases (106 patients) were analyzed: 73 cases with survey and registries and 35 with registries only. The main most frequent reasons for consultation were adequacy of therapeutic effort (46/42.6%), severe neurological involvement (15/13.9%), patient's quality of life (11/10.2%), patient-family-health system conflict (7/6.5%), and family's refusal of treatment (6/5.6%). High levels of satisfaction (> 95%) and moderate levels of feasibility (> 74%) and effectiveness (> 85%) were observed. In only 50/108 cases (46.3%), the consultation with the CEC was registered in the medical record, 44% of health care providers stated that the consultation had a positive impact on the patient and their family. Results helped to establish improvement opportunities, especially in terms of documentation and communication in the consultation process.

Atrial fibrillation (AF) pilot screening programme in primary care in Ireland: an implementation study protocol

IntroductionAtrial fibrillation (AF) is a major risk factor for stroke. There is a fivefold increase in stroke risk in the presence of AF. The irregular beating of the heart enables...

Double-blind placebo-controlled randomized clinical trial to assess the efficacy of montelukast in mild to moderate respiratory symptoms of patients with long COVID: E-SPERANZA COVID Project study protocol

BackgroundThe coronavirus disease 2019 (COVID-19) pandemic continues to affect the globe. After 18 months of the SARS-CoV-2 emergence, clinicians have clearly defined a subgroup of patients with lasting, disabling symptoms. While big strides have been made in understanding the acute phase of SARS-CoV-2 infection, the pathophysiology of long COVID is still largely unknown, and evidence-based, effective treatments for this condition remain unavailable.ObjectivesTo evaluate the efficacy of 10 mg oral montelukast every 24 h versus placebo in improving quality of life associated with mild to moderate respiratory symptoms in patients with long COVID as measured with the COPD Assessment Test (CAT) questionnaire. The secondary objectives will evaluate the effect of montelukast versus placebo on improving exercise capacity, COVID-19 symptoms (asthenia, headache, mental confusion or brain fog, ageusia, and anosmia), oxygen desaturation during exertion, functional status, and mortality.Methods and analysisPhase III, randomized, double-blind clinical trial. We will include 18- to 80-year-old patients with SARS-CoV-2 infection and mild to moderate respiratory symptoms lasting more than 4 weeks. Participants will be randomly allocated in a 1:1 ratio to the intervention (experimental treatment with 10 mg/day montelukast) or the control group (placebo group), during a 28-day treatment. Follow-up will finish 56 days after the start of treatment. The primary outcome will be health-related quality of life associated with respiratory symptoms according to the COPD Assessment Test 4 weeks after starting the treatment. The following are the secondary outcomes: (a) exercise capacity and oxygen saturation (1-min sit-to-stand test); (b) Post-COVID-19 Functional Status Scale; (c) other symptoms: asthenia, headache, mental confusion (brain fog), ageusia, and anosmia (Likert scale); (d) use of healthcare resources; (e) mortality; (f) sick leave duration in days; and (g) side effects of montelukast.Ethics and disseminationThis study has been approved by the Clinical Research Ethics Committee of the IDIAPJGol (reference number 21/091-C). The trial results will be published in open access, peer-reviewed journals and explained in webinars to increase awareness and understanding about long COVID among primary health professionals.Trial registrationClinicalTrials.govNCT04695704. Registered on January 5, 2021. EudraCT number 2021-000605-24. Prospectively registered.

Diagnostic and prognostic value of Nesfatin-1 in sepsis and septic shock

Nesfatin-1 is an anorectic protein, and we expect it to decrease during sepsis and septic shock. We aimed to analyze it and determine the relationship between Nesfatin-1 levels and quick Sequential Organ Failure Assessment(qSOFA) score, renal Sequential Organ Failure Assessment (SOFA) score, and mortality in patients with sepsis and septic shock. Sixty-nine hospitalized adult patients diagnosed with sepsis and septic shock in the internal medicine department, were included in the study after approval of the Clinical Research Ethics Committee. Sepsis diagnosis was based on the detected focus of infection, positive blood cultures, and response to antibiotics. Twenty-one healthy controls matched for age and sex with these patients were also included in the study. Sixty-nine septic patients and twenty-one healthy volunteers were included in the study. Nesfatin-1 levels were compared with covariates. Nesfatin-1 levels in septic patients were lower than that of healthy controls. There was no significant difference in Nesfatin-1 between diabetic and non-diabetic subgroups. Patients with quick Sequential Organ Failure Assessment (qSOFA) score of three had a statistically significantly lower Nesfatin-1 level than those of patients with the score of zero, one, and two. Nesfatin-1 was correlated negatively with C reactive protein. We found a statistically significant difference in 1-month mortality between Nesfatin-1 levels below and over 80pg/mL. In order to use Nesfatin-1 as a biomarker in differentiating sepsis from healthy population, more comprehensive and more studies are needed. If supported by new studies, Nesfatin-1 levels below 80 pg / mL at first admission in septic patients may direct the clinician to broad-spectrum antibiotic therapy and earlier intensive care follow-up.

An evaluation of thrombocytopenia cases in the hematology clinic of the Ankara Numune Training and Research Hospital

Background Thrombocytopenia is a major disease that requires the referral of outpatient and hospitalized patients to hematology specialists. Objectives The present study aims to evaluate the laboratory and transfusion statuses of adult patients admitted to our hospital and receiving outpatient/inpatient treatment and diagnosed with thrombocytopenia (&lt;100 × 109/l). Design Single-center, retrospective, laboratory-based study. Patients and methods In the study, after obtaining permission of the hospital's Non-Invasive Clinical Research Ethics Committee, the information of patients diagnosed with thrombocytopenia (platelet count &lt;100 × 109/l) and who were examined and treated in the outpatient/inpatient settings between 2008 and 2010 were retrospectively analyzed using patient files and the hospital electronic database. Sample size A total of 1020 patients diagnosed with thrombocytopenia. Results The patients were divided into groups according to the most common diagnoses for diseases associated with thrombocytopenia (hematological malignancy, disseminated intravascular coagulation (DIC)-sepsis, immune thrombocytopenia (ITP), infection, and chronic liver disease (n=708). Chemotherapy-induced, drug-induced, nutritional (B12, folate deficiency, etc.), OKIT, pregnancy-induced thrombocytopenias and other less common causes of thrombocytopenia were evaluated in a separate group (n=312). It was found that female patients were more frequently diagnosed with ITP (71.7 vs. 28.3%). Sex distributions were similar in other groups. The highest mean age (71 years: 50/80) was observed in patients with DIC-sepsis, whereas the lowest mean age was found in patients with ITP (40 years: 30/57) (P&lt;0.001). It was found that the most frequent need for transfusion developed in patients diagnosed with acute myeloid leukemia, acute lymphoblastic leukemia, and aplastic anemia. Conclusion In this study, it was determined that the prevalence of thrombocytopenia was highest in patients diagnosed with hematological malignancy, ITP, and DIC-sepsis, respectively. In cases of hematological malignancy, the need for replacement of blood products is considered to be inevitable during the treatment process of the underlying disease compared with other clinical conditions.

MRI utilization in pediatric emergency department: An analysis over 5 years

There are concerns on exposure to radiation especially in pediatric population, as magnetic resonance imaging (MRI) can be used in emergency departments and provides an imaging without radiation; its utilization has recently increased. This study aimed to evaluate MRI utilization trends in patients who underwent a MRI in a pediatric emergency department within a period of five years. Examination data of the patients admitted to pediatric emergency department between 2014 and 2018 were obtained from database of the hospital with the approval of Clinical Research Ethical Committee. Rate of MRI utilization in patients admitted to pediatric emergency department was 0.88%. There was a statistically significant increase in MRI utilization within five years (p&lt;0.001). The rate of male patients (1.24%) who underwent MRI was significantly higher than that of female patients (0.65%) (p&lt;0.0001). There was a statistically significant decrease in MRI utilization by age in all categories (p&lt;0.0001). Neuroradiology imaging was the most common. Complaints at presentation and pre-diagnoses were analyzed. The results of MRI were evaluated by radiologists and 53.9% of the results were normal. The highest rate (46.1%) of MRI utilization was between 4 pm and 12 am in a day. The highest rate of MRI utilization was on Friday and the lowest rate was on Sunday. While MRI utilization has increased in pediatric patients, neuroradiology imaging is the most common type. MRI utilization in pediatric emergency department is higher in male patients and in the early ages.

Common Errors in Clinical Research Ethics Committee Applications: The Experience of A Training and Research Hospital

Common Errors in Clinical Research Ethics Committee Applications: The Experience of A Training and Research Hospital

Effectiveness of Derivo® Flow Diverter Device in the Endovascular Treatment of Cerebrovascular Aneurysms.

To report our experience with flow diverter devices in the treatment of intracranial aneurysms, and to share the efficacy and clinical results of the Derivo® flow diverter device in the endovascular treatment of cerebrovascular aneurysms. This retrospective study was conducted at a regional training and research hospital between October 2015 and March 2020 after approval by the Clinical Research Ethics Committee. The radiology and file records of 21 patients with cerebrovascular aneurysms treated endovascularly using a Derivo® flow diverter device were examined. As per our findings, flow diverter devices were used to treat 27 aneurysms from 21 cases. Among the treated aneurysms, 3, 2, and 22 were in the middle cerebral artery, anterior communicating artery, and internal cerebral artery, respectively. Eight of the patients with a mean age of 56.9 years presented with subarachnoid hemorrhage. Derivo® flow diverters were used alone in 19 cases, whereas concurrent diverter device and coiling were used in only 3 patients. Complete closure of the aneurysms was observed in 3 (14.2%) cases; meanwhile, a 50% reduction in aneurysm size was observed in 2 (9.5%) cases. Complete aneurysm closure occurred in 20 cases (95%) at the 6-month follow-up. Mortality and morbidity each occurred in 1 (4.7%) case. Flow diverter devices provide an efficient and safe method of treatment, especially for fusiform, large, giant, widenecked intracranial aneurysms. Endovascular coil embolization treatment is deemed inappropriate for small aneurysms.