scholarly journals ETHICAL ISSUES IN CLINICAL TRIALS: A REVIEW OF THE RECENT LITERATURE, AN ETHICAL ARGUMENTATION

2021 ◽  
Vol 9 (01) ◽  
pp. 1079-1086
Author(s):  
Maria Aziz ◽  
◽  
Azma J. Khan ◽  
Sefia Khan ◽  
◽  
...  
Keyword(s):  
Clinical Trials ◽  
Patient Care ◽  
Ethical Issues ◽  
Meta Analysis ◽  
Clinical Care ◽  
Well Being ◽  
Best Interest ◽  
Inform Consent ◽  
Definition Of ◽  
Ethical Oversight

Purpose: To identify ethical issues and risks involved in clinical trials and develop a conceptual model of identified issues in patient safety in clinical trials. Methodology: The review comprises of qualitative meta-analysis of available literature to identify potential ethical issues involved in the field of clinical trials. Findings: Our review identifies gaps in following core areas: 1) Research vs. Practice; 2) Inform Consent; 3) Ethical Oversight. Existing literature shows gaps in the true definition of research and does not clarify points of difference to clinical care. Existing guidelines are still confusing about the requirement of inform consent, in which cases it is mandatory and in which cases it should be waived off. There are indiscripencies, how much information should be provided in the inform consent disclosure. Is ethical oversight required in all research studies and if so at what level. We will build a streamline ethical argumentation to identify gaps in the existing literature, evaluate existing guidelines, analyze the contents to reach a conclusion and put forward recommendations for quality improvement. Conclusions: For the definition of research and its difference with clinical practice, decision should be taken in the best interest of the patient whether it is patient care or it is research.For ethical overview oversight, we suggest concept of proportionate review. Inform consent should be seeked in all researches but if becomes a barrier in patient care then waiver should be granted for the well-being of the patient. All information should be disclosed to the research participants so that they make an informed decision for their participation.

scholarly journals Identification and inclusion of gender factors in retrospective cohort studies: the GOING-FWD framework

2021 ◽  
Vol 6 (4) ◽  
pp. e005413
Author(s):  
Valeria Raparelli ◽  
Colleen M. Norris ◽  
Uri Bender ◽  
Maria Trinidad Herrero ◽  
Alexandra Kautzky-Willer ◽  
...  
Keyword(s):  
Outcome Measurement ◽  
Meta Analysis ◽  
Synthetic Data ◽  
Well Being ◽  
Pooled Analysis ◽  
Research Network ◽  
Local Analysis ◽  
Related Factors ◽  
Measurement Framework ◽  
Definition Of

Gender refers to the socially constructed roles, behaviours, expressions and identities of girls, women, boys, men and gender diverse people. Gender-related factors are seldom assessed as determinants of health outcomes, despite their powerful contribution. The Gender Outcomes INternational Group: to Further Well-being Development (GOING-FWD) project developed a standard five-step methodology applicable to retrospectively identify gender-related factors and assess their relationship to outcomes across selected cohorts of non-communicable chronic diseases from Austria, Canada, Spain, Sweden. Step 1 (identification of gender-related variables): Based on the gender framework of the Women Health Research Network (ie, identity, role, relations and institutionalised gender), and available literature for a certain disease, an optimal ‘wish-list’ of gender-related variables was created and discussed by experts. Step 2 (definition of outcomes): Data dictionaries were screened for clinical and patient-relevant outcomes, using the International Consortium for Health Outcome Measurement framework. Step 3 (building of feasible final list): a cross-validation between variables per database and the ‘wish-list’ was performed. Step 4 (retrospective data harmonisation): The harmonisation potential of variables was evaluated. Step 5 (definition of data structure and analysis): The following analytic strategies were identified: (1) local analysis of data not transferable followed by a meta-analysis combining study-level estimates; (2) centrally performed federated analysis of data, with the individual-level participant data remaining on local servers; (3) synthesising the data locally and performing a pooled analysis on the synthetic data and (4) central analysis of pooled transferable data. The application of the GOING-FWD multistep approach can help guide investigators to analyse gender and its impact on outcomes in previously collected data.

scholarly journals The Gender Outcomes International Group: to Further Well-being Development (Going-fwd) Methodology on Identification and Inclusion of Gender Factors in Retrospective Cohort Studies

2020 ◽  
Author(s):  
Valeria Raparelli Raparelli ◽  
Colleen M. Norris ◽  
Uri Bender ◽  
Maria Trinidad Herrero ◽  
Alexandra Kautzky-Willer ◽  
...  
Keyword(s):  
Data Structure ◽  
Meta Analysis ◽  
Synthetic Data ◽  
Well Being ◽  
Pooled Analysis ◽  
Research Network ◽  
Local Analysis ◽  
Related Factors ◽  
Individual Level ◽  
Definition Of

Abstract Background: Gender refers to the socially constructed roles, behaviors, expressions, and identities of girls, women, boys, men, and gender diverse people. It influences self-perception, individual’s actions and interactions, as well as the distribution of power and resources in society. Gender-related factors are seldom assessed as determinants of health outcomes, despite their powerful contribution.Methods: Investigators of the GOING-FWD project developed a standard methodology applicable for observational studies to retrospectively identify gender-related factors to assess their relationship to outcomes and applied this method to selected cohorts of non-communicable chronic diseases from Austria, Canada, Spain, Sweden.Results: The following multistep process was applied. Step 1 (Identification of Gender-related Variables): Based on the gender framework of the Women Health Research Network (i.e. gender identity, role, relations, and institutionalized gender), and available literature for a certain disease, an optimal “wish-list” of gender-related variables/factors was created and discussed by experts. Step 2 (Definition of Outcomes): each of the cohort data dictionaries were screened for clinical and patient relevant outcomes, using the ICHOM framework. Step 3 (Building of Feasible Final List): A cross-validation between gender-related and outcome variables available per database and the “wish-list” was performed. Step 4 (Retrospective Data Harmonization): The harmonization potential of variables was evaluated. Step 5 (Definition of Data Structure and Analysis): Depending on the database data structure, the following analytic strategies were identified: (1) local analysis of data not transferable followed by a meta-analysis combining study-level estimates; (2) centrally performed federated analysis of anonymized data, with the individual-level participant data remaining on local servers; (3) synthesizing the data locally and performing a pooled analysis on the synthetic data; and (4) central analysis of pooled transferable data.Conclusion: The application of the GOING-FWD systematic multistep approach can help guide investigators to analyze gender and its impact on outcomes in previously collected data.

scholarly journals Well-Being and Romantic Relationships: A Systematic Review in Adolescence and Emerging Adulthood

2019 ◽  
Vol 16 (13) ◽  
pp. 2415 ◽  
Author(s):  
Mercedes Gómez-López ◽  
Carmen Viejo ◽  
Rosario Ortega-Ruiz
Keyword(s):  
Systematic Review ◽  
Romantic Relationships ◽  
Emerging Adulthood ◽  
Emerging Adults ◽  
Meta Analysis ◽  
Well Being ◽  
The Other ◽  
The One ◽  
Definition Of ◽  
The Relationship

Adolescence and emerging adulthood are both stages in which romantic relationships play a key role in development and can be a source of both well-being and negative outcomes. However, the limited number of studies prior to adulthood, along with the multiplicity of variables involved in the romantic context and the considerable ambiguity surrounding the construct of well-being, make it difficult to reach conclusions about the relationship between the two phenomena. This systematic review synthesizes the results produced into this topic over the last three decades. A total of 112 studies were included, following the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) guidelines. On the one hand, these works revealed the terminological heterogeneity in research on well-being and the way the absence of symptoms of illness are commonly used to measure it, while on the other hand, they also showed that romantic relationships can be an important source of well-being for both adolescents and emerging adults. The findings underline the importance of providing a better definition of well-being, as well as to attribute greater value to the significance of romantic relationships. Devoting greater empirical, educational, and community efforts to romantic development in the stages leading up to adulthood are considered necessary actions in promoting the well-being of young people.

scholarly journals The Clinical Effects of Cerebral Near-Infrared Spectroscopy Monitoring (NIRS) Versus No Monitoring in Children and Adults: A Protocol for a Systematic Review With Meta-Analysis and Trial Sequential Analysis

2020 ◽  
Author(s):  
Mathias Lühr Hansen ◽  
Simon Hyttel-Sørensen ◽  
Janus Christian Jakobsen ◽  
Christian Gluud ◽  
Elisabeth M.W. Kooi ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Infrared Spectroscopy ◽  
Sequential Analysis ◽  
Near Infrared ◽  
Meta Analysis ◽  
Clinical Care ◽  
Trial Sequential Analysis ◽  
Clinical Settings ◽  
Ischaemic Brain

Abstract BackgroundMultiple clinical conditions are associated with cerebral hypoxia/ischaemia and thereby an increased risk of hypoxic-ischaemic brain injury. Cerebral near-infrared spectroscopy monitoring (NIRS) is a tool to monitor brain oxygenation and perfusion, and the clinical uptake of NIRS has expanded over recent years. Specifically, NIRS is used in the perioperative and neonatal, paediatric, and adult intensive care settings. However, the available literature suggests that clinical benefits and harms of cerebral NIRS monitoring are uncertain. As rates of clinically significant hypoxic-ischaemic brain injuries are typically low, it is difficult for randomised clinical trials to capture a sufficiently large number of events to evaluate the clinical effect of cerebral NIRS monitoring, when focusing on specific clinical settings. MethodsWe will conduct a systematic review with meta-analysis and Trial Sequential Analysis to evaluate the benefits and harms of clinical care with cerebral NIRS monitoring versus clinical care without cerebral NIRS monitoring in children and adults across all clinical settings. We will only include randomised clinical trials and the primary outcomes are all-cause mortality, moderate or severe persistent cognitive or neurological deficit, and proportion of participants with one or more serious adverse events. The review will be conducted according to the methodology described in The Cochrane Handbook for Systematic Reviews of Interventions, including GRADE. An eight-step procedure by Jakobsen et al. will be used to assess if thresholds for statistical and clinical significance are crossed.DiscussionAs we include trials across multiple clinical settings, there is an increased probability of reaching a sufficient information size. However, heterogeneity between the included trials may impair our ability to interpret results to specific clinical settings. In this situation, we may have to depend on subgroup analyses with inherent increased risks of type I and II errors. Systematic review registrationThis systematic review protocol has been submitted for registration in the International Prospective Register of Systematic Reviews (PROSPERO) (http://www.crd.york.ac.uk/prospero) (1,2) on 12th of October 2020.

The effectiveness of mHealth interventions on postpartum depression: A systematic review and meta-analysis

2020 ◽  
pp. 1357633X2091781
Author(s):  
Chuqing Zhou ◽  
Hua Hu ◽  
Chunyi Wang ◽  
Ziyu Zhu ◽  
Gengchen Feng ◽  
...  
Keyword(s):  
Systematic Review ◽  
Postpartum Depression ◽  
Large Scale ◽  
Meta Analysis ◽  
Clinical Care ◽  
Intervention Group ◽  
Depression Scale ◽  
Clinical Effectiveness ◽  
Well Being ◽  
Cochrane Library

Introduction Postpartum depression (PPD) is a common psychiatric condition during the postnatal period that negatively impacts the well-being of both the mother and her infant. This study describes a systematic review and preliminary meta-analysis to assess the efficacy of mobile health (mHealth) interventions, which is defined as the use of portable electronic devices to support public health and medical practice, in addressing depressive symptoms among postpartum women. Methods Databases including PubMed, PsycINFO, the Cochrane Library, Embase and ClinicalTrials.gov were searched for randomized controlled trials (RCTs) assessing the effectiveness of mHealth interventions on PPD from database inception to December 2019. Results The initial search identified 754 studies, of which, 11 studies fulfilled the inclusion criteria. These studies evaluated four types of distinct mHealth interventions and involved 2424 participants across six countries. Pooled results demonstrated that compared to the controls, the Edinburgh Postnatal Depression Scale score decreased in the mHealth intervention group (mean difference: –1.09, 95% confidence interval: –1.39 to –0.79). Discussion Our study suggested that mHealth interventions may be a promising tool to complement routine clinical care in the prevention and treatment of PPD, but the clinical effectiveness of mHealth interventions needs to be better established. While most studies focused on telephone-based interventions, recent researches have also suggested the superiority and effectiveness of short messaging service (SMS) and smartphone applications, but the exact efficacy needs further evaluation. Therefore, more high-quality RCTs on app-based and SMS-based interventions are needed before the large-scale roll-out of these interventions in clinical practice.

Abstract 242: Can Belief Enhance Relief? A Multicenter Study

2018 ◽  
Vol 11 (suppl_1) ◽  
Author(s):  
Abbas Alshami ◽  
America Avila ◽  
Carlos Romero ◽  
Raphael Villarreal ◽  
Sharon Einav ◽  
...  
Keyword(s):  
Quality Of Care ◽  
Patient Care ◽  
Ethical Issues ◽  
Belief Systems ◽  
Statistical Significance ◽  
Healthcare Providers ◽  
Well Being ◽  
Physical Symptoms ◽  
Personal Beliefs

Purpose: While caring for patients, it is important to recognize more than just the apparent physical symptoms. Their emotional well-being, level of comfort, and spiritual concerns are relevant and should be taken into consideration. We aimed to identify if a greater commitment to spiritual belief systems by healthcare providers could have an effect on the patient care they provided. Methods: The Ethics in Intensive Care Study (ETHICS) was conducted in multiple centers all over the world utilizing a confidential survey. Questions were related to personal opinions on ethical issues, including personal beliefs, and patient care. We hypothesized that the personal beliefs of the healthcare providers should not affect the quality of care provided. Pearson’s correlation was used to ascertain statistical significance. Results: A total of 9,720 healthcare providers rated their level of spirituality from 1 (least) to 10 (greatest), and answered whether their beliefs affected their patient care. The majority of the people surveyed (65.6%; n=6,378) assessed themselves between 5 and 8 out of 10. In each individual level, most physicians felt patient care was not affected. However, on closer inspection and analysis, an interesting trend emerged. Only 11.4% (n=45) of those who rated themselves in level 1 of spirituality (n=394) stated their patient care was affected by their personal beliefs. Of people in level 5 (n=1,300), 13.3% (n=173) felt their beliefs affect the quality of care provided, and surprisingly, that number increased to 21.4% (n=193) among those healthcare provider rated in level 10 (n=899) [ p <0.001, Pearson’s R correlation 0.94]. Conclusions: A significant number of physicians identify themselves as religious, whether by belief in God, or based on a level of spirituality. We found a strong correlation between the level of spirituality a provider feels and the perception of how much his/her patient care is affected. We are not aware if this translates into real differences in patient care.

Forensic Psychiatry in the Elderly-ethical Issues

2009 ◽  
Vol 24 (S1) ◽  
pp. 1-1
Author(s):  
N. Tataru
Keyword(s):  
Mental Health ◽  
Forensic Psychiatry ◽  
Ethical Issues ◽  
Well Being ◽  
The Elderly ◽  
Short Review ◽  
Involuntary Commitment ◽  
Ethical Aspect ◽  
Best Interest ◽  
Care Needs

We discuss about psychiatric and psychological expertise exams and about the assessment of competence in the elderly and ethical aspect of care and research in elderly demented or not demented people and about involuntary commitment of incompetent patients.We also refer to the complications and difficulties when trying to apply the civil commitments compulsive hospital admission measure, foreseen in the law for mental health, when the dementia diagnostic falls within this age group. Historically, involuntary commitment of incompetent patients took in the consideration the best interest of the patient, but also the well-being of the family and the potential risk for others.After a short review of legislation and of conditions of hospitalization concerning involuntary commitment of the mentally ill people during our history before and after 1989, we'll analyze the activity on involuntary commitment in a Forensic Psychiatry Hospital in district Bihor, in last five years from a 30 years experience working in the field. Standards and practice in our country regarding the involuntary commitment have been changed more that three times after the second War and has been improved in 2002, when there appeared the new Mental Health Law, emphasizing protection of patients’ rights. There are legal and ethical limits to involuntary hospitalisation, because involuntary treatment and hospitalisation restricts a person's liberty. There should be a lot of things to do to improve the quality standards: improvement of elementary care needs, improvement of their quality of life.

scholarly journals How to continue COVID-19 vaccine clinical trials? The ethics of vaccine research in a time of pandemic

2021 ◽  
pp. 147775092110524
Author(s):  
Silvia Ceruti ◽  
Marco Cosentino ◽  
Mario Picozzi
Keyword(s):  
Clinical Trials ◽  
Ethical Issues ◽  
Vaccination Campaign ◽  
Scientific Information ◽  
Well Being ◽  
Resource Scarcity ◽  
European Medicines Agency ◽  
Human Beings ◽  
Controlled Clinical Trials ◽  
The Us

Between December 2020 and March 2021, the US Food and Drug Administration and the European Medicines Agency issued Emergency Use Authorizations and Conditional Marketing Authorizations for the distribution of the first COVID-19 vaccines. Although these vaccines were thoroughly assessed before their approval, regulators required companies to continue ongoing placebo-controlled clinical trials in order to gather further reliable scientific information on their safety and efficacy, as well as to start new studies to evaluate additional candidates. The aim of this paper is to present and discuss the ethical issues raised by the tension between the need to continue these types of clinical trials and the obligations related to the protection of the rights and well-being of research participants. Specifically, we question whether—how, and to what extent—fundamental principles governing research involving human beings can be applied to the current pandemic situation. We argue that continuing ongoing placebo-controlled clinical trials can be considered ethically justifiable only if all participants are adequately informed of any developments that may affect their willingness to remain enrolled, including the current situation of resource scarcity and the prioritization criteria established for vaccination. However, we also argue that currently approved vaccines, which are considered safe and effective enough to be administered to millions of people as part of the vaccination campaign, necessarily represent the “best proven intervention” currently available and, therefore, should be used as comparators in future studies instead of placebo.

Framing holistic indoor environment: Definitions of comfort, health and well-being

2019 ◽  
Vol 29 (8) ◽  
pp. 1118-1136 ◽  
Author(s):  
Lasse Rohde ◽  
Tine Steen Larsen ◽  
Rasmus Lund Jensen ◽  
Olena Kalyanova Larsen
Keyword(s):  
Meta Analysis ◽  
Well Being ◽  
Indoor Environmental Quality ◽  
Ontological Approach ◽  
Formal Definitions ◽  
Positive Experiences ◽  
Enriched Environments ◽  
Definition Of ◽  
Positive Stimuli ◽  
Health And Well Being

In research and assessment of indoor environmental quality (IEQ), the terms ‘Comfort’, ‘Health’ and ‘Well-being’ are often used interchangeably without a clear definition of terms or effects on conditions for occupants. This calls for a systematic restructuring of the ontological approach to IEQ and, based on a meta-analysis of recent IEQ literature, the authors suggest three substantial contributions: 1) A framework consisting of comfort, health and well-being as three equal branches of IEQ to increase focus on previously neglected aspects and make inter-domain relations more transparent. 2) The identification of key IEQ trends and by extension suggestions for formal definitions of three main domains as part of a multidisciplinary conceptual framework for working holistically with IEQ. 3) The introduction of positive stimuli to IEQ assessment as opposed to the predominance of focus on the absence of negative parameters of current practice. Through including this positive stimuli dimension, the field of IEQ shifts from ‘not bad’ to ‘truly good’, encouraging the design of enriched environments to further positive experiences improving occupant well-being.

scholarly journals Efficacy of Meaning-Centered Psychotherapy in adult patients with advanced cancer: A systematic review and meta-analysis

2021 ◽  
Vol 18 (2) ◽  
pp. 227-244
Author(s):  
Natalia Dietrich ◽  
Andrés Estradé ◽  
Juan Antonio Cruzado
Keyword(s):  
Quality Of Life ◽  
Systematic Review ◽  
Clinical Trials ◽  
Psychological Distress ◽  
Advanced Cancer ◽  
Meta Analysis ◽  
Well Being ◽  
Adult Patients ◽  
Spiritual Well Being

Objective: We conducted a PRISMA-compliant systematic review of clinical trials, and a meta-analysis of randomised clinical trials (RCTs) of manualised Meaning-Centered Psychotherapy (MCP) interventions for adult advanced cancer patients. We searched seven databases for trials published in English and Spanish, until March 27, 2021. Results: Seven trials were included in the systematic review, and four in the meta-analysis. The systematic review favoured the effectiveness of MCP for the improvement of spiritual well-being, quality of life (QoL), sense of meaning and psychological distress, although inconsistencies between the trials were found. In pre-post meta-analytic estimates, MCP had a superior therapeutic effect than control conditions for spiritual well-being (d=0.52, p<0.001), QoL (d=0.60, p<0.001), anxiety symptoms (d=-0.47, p<0.001), depressive symptoms (d=-0.50, p<0.001) and desire for hastened death (d=-0.28, p<0.001). No differences were observed in between-group comparisons. MCP was not associated with an increased risk of abandonment at post-treatment (OR=0.86, p=0.57). Conclusion: Manualised MCP interventions are a promising treatment for the improvement of spiritual well-being and quality of life and the reduction of psychological distress in adult patients with advanced cancer. The evidence base is still in an emerging state and should be expanded by higher methodological quality studies.

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