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Journal of Medical Internet Research Sep 2023Providing informed consent means agreeing to participate in a clinical trial and having understood what is involved. Flawed informed consent processes, including missing... (Review)
Review
BACKGROUND
Providing informed consent means agreeing to participate in a clinical trial and having understood what is involved. Flawed informed consent processes, including missing dates and signatures, are common regulatory audit findings. Electronic consent (eConsent) uses digital technologies to enable the consenting process. It aims to improve participant comprehension and engagement with study information and to address data quality concerns.
OBJECTIVE
This systematic literature review aimed to assess the effectiveness of eConsent in terms of patient comprehension, acceptability, usability, and study enrollment and retention rates, as well as the effects of eConsent on the time patients took to perform the consenting process ("cycle time") and on-site workload in comparison with traditional paper-based consenting.
METHODS
The systematic review was conducted and reported in accordance with the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. Ovid Embase and Ovid MEDLINE were systematically searched for publications reporting original, comparative data on the effectiveness of eConsent in terms of patient comprehension, acceptability, usability, enrollment and retention rates, cycle time, and site workload. The methodological validity of the studies that compared outcomes for comprehension, acceptability, and usability across paper consent and eConsent was assessed. Study methodologies were categorized as having "high" validity if comprehensive assessments were performed using established instruments.
RESULTS
Overall, 37 publications describing 35 studies (13,281 participants) were included. All studies comparing eConsenting and paper-based consenting for comprehension (20/35, 57% of the studies; 10 with "high" validity), acceptability (8/35, 23% of the studies; 1 with "high" validity), and usability (5/35, 14% of the studies; 1 with "high" validity) reported significantly better results with eConsent, better results but without significance testing, or no significant differences in overall results. None of the studies reported better results with paper than with eConsent. Among the "high" validity studies, 6 studies on comprehension reported significantly better understanding of at least some concepts, the study on acceptability reported statistically significant higher satisfaction scores, and the study on usability reported statistically significant higher usability scores with eConsent than with paper (P<.05 for all). Cycle times were increased with eConsent, potentially reflecting greater patient engagement with the content. Data on enrollment and retention were limited. Comparative data from site staff and other study researchers indicated the potential for reduced workload and lower administrative burden with eConsent.
CONCLUSIONS
This systematic review showed that compared with patients using paper-based consenting, patients using eConsent had a better understanding of the clinical trial information, showed greater engagement with content, and rated the consenting process as more acceptable and usable. eConsent solutions thus have the potential to enhance understanding, acceptability, and usability of the consenting process while inherently being able to address data quality concerns, including those related to flawed consenting processes.
Topics: Humans; Data Accuracy; Digital Technology; Electronics; Informed Consent; Patient Participation
PubMed: 37656499
DOI: 10.2196/43883 -
Public Health Nov 2023Dengue is the most important human vector-borne disease in terms of disease burden. A first dengue vaccine has recently been licenced, and others are in advanced stages... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
Dengue is the most important human vector-borne disease in terms of disease burden. A first dengue vaccine has recently been licenced, and others are in advanced stages of development. However, to date, none of these vaccines has achieved balanced efficacy and safety for all dengue serotypes. The aim of this systematic review and meta-analysis was to assess the global acceptance and willingness to pay for unspecified dengue vaccines.
METHODS
This systematic review and meta-analysis included cross-sectional and cohort studies that reported values for vaccine acceptance (percentage) and willingness to pay for currently available or hypothetical vaccines. These values were pooled using random-effects models for the acceptance, while weighted linear regression was chosen for willingness to pay. Heterogeneity between studies was assessed using prediction intervals (PIs), and a domain-based tool was used to assess the risk of bias. Subgroup and sensitivity analyses were performed where appropriate. This study was registered with PROSPERO (CRD42021255784).
RESULTS
We included 19 studies from the Americas and Asia in the quantitative meta-analysis. The risk of bias was mainly related to the selection of participants and to the assumptions about the safety and efficacy of the vaccines. The percentage of vaccine acceptance was 88.3% (95% CI: 81.0%-93.0%), with some heterogeneity between studies (80% PI: 52.9%-98.1%). Willingness to pay was US$ 46.7 (95% CI: 25.9-67.5) per vaccine recipient. There were differences between continents, with higher acceptance in the Americas.
CONCLUSIONS
We were able to obtain global estimates of vaccine acceptance and willingness to pay and identify the associated factors that influence these values. This knowledge is relevant for the planning of future vaccination strategies.
Topics: Humans; Dengue Vaccines; Dengue; Patient Acceptance of Health Care; Vaccination Hesitancy
PubMed: 37741155
DOI: 10.1016/j.puhe.2023.08.022 -
Italian Journal of Pediatrics Jul 2023Robust routine immunization schedules for pertussis-containing vaccines have been applied for years, but pertussis outbreaks remain a worldwide problem. This study aimed... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Robust routine immunization schedules for pertussis-containing vaccines have been applied for years, but pertussis outbreaks remain a worldwide problem. This study aimed to investigate the association between vaccine hesitancy and pertussis in infants and children.
METHODS
We searched PubMed, Cochrane, Web of Science, Embase, and China National Knowledge Internet for studies published between January 2012 and June 2022. This study included case-control and cohort studies that assessed the association between childhood/maternal vaccine hesitancy and odds ratios (ORs), risk ratios (RRs), and vaccine effectiveness (VE) related to pertussis in infants and children [Formula: see text] 9 years old. ORs/VEs with a 95% confidence interval (CI) were calculated. Random-effects meta-analysis models were used for appropriate pooled estimates, and heterogeneity was assessed using [Formula: see text]. Cumulative meta-analysis and subgroup analyses stratified by study characteristics were performed.
RESULTS
Twenty-two studies were included, with a mean quality score of 7.0 (range 6.0-9.0). Infants and children with pertussis were associated with higher vaccine hesitancy to all doses (OR = 4.12 [95% CI: 3.09-5.50]). The highest OR was between children who were unvaccinated over four doses and children who were fully vaccinated (OR = 14.26 [95%CI: 7.62-26.70]); childhood vaccine delay was not statistically significantly associated with pertussis risk (OR = 1.18 [95% CI: 0.74-1.89]). Maternal vaccine hesitancy was associated with significantly higher pertussis risk in infants aged 2 and 3 months old, with higher pertussis ORs in infants [Formula: see text] 2 months old (OR = 6.02 [95%CI: 4.31-8.50], OR = 5.14 [95%CI: 1.95-13.52] for infants [Formula: see text] 2 and [Formula: see text] 3 months old, respectively). Maternal and childhood VEs were high in reducing pertussis infection in infants and children. The administration time of maternal vaccination had little effect on VE.
CONCLUSION
Vaccine hesitancy increased pertussis risks in infants and children. Ensuring that children receive up-to-date pertussis vaccines is essential; short delays in receiving childhood vaccinations may be unimportant. Maternal vaccinations for pertussis should be encouraged.
Topics: Child; Infant; Humans; Whooping Cough; Vaccination Hesitancy; Vaccination; Immunization Schedule; Vaccines
PubMed: 37443026
DOI: 10.1186/s13052-023-01495-8 -
The Lancet. Psychiatry Oct 2023Ketamine is an effective antidepressant, but there is substantial variability in patient response and the precise mechanism of action is unclear. Neuroimaging can... (Review)
Review
Ketamine is an effective antidepressant, but there is substantial variability in patient response and the precise mechanism of action is unclear. Neuroimaging can provide predictive and mechanistic insights, but findings are limited by small sample sizes. This systematic review covers neuroimaging studies investigating baseline (pre-treatment) and longitudinal (post-treatment) biomarkers of responses to ketamine. All modalities were included. We performed searches of five electronic databases (from inception to April 26, 2022). 69 studies were included (with 1751 participants). There was substantial methodological heterogeneity and no well replicated biomarker. However, we found convergence across some significant results, particularly in longitudinal biomarkers. Response to ketamine was associated with post-treatment increases in gamma power in frontoparietal regions in electrophysiological studies, post-treatment increases in functional connectivity within the prefrontal cortex, and post-treatment increases in the functional activation of the striatum. Although a well replicated neuroimaging biomarker of ketamine response was not identified, there are biomarkers that warrant further investigation.
Topics: Humans; Ketamine; Brain; Antidepressive Agents; Neuroimaging; Biomarkers
PubMed: 37625426
DOI: 10.1016/S2215-0366(23)00183-9 -
Journal of Clinical Nursing Aug 2023To analyse research-based evidence about patients' right to know from their own perspective to promote ethically high-quality nursing and to identify future research...
AIMS AND OBJECTIVES
To analyse research-based evidence about patients' right to know from their own perspective to promote ethically high-quality nursing and to identify future research areas.
BACKGROUND
Patients' right to know is a fundamental right. Although of topical research interest, the current state of scientific evidence on patients' right to know has not been reviewed.
DESIGN
A scoping review according to the methodological framework by Arksey & O'Malley and the Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews.
METHODS
In June 2022, a literature search was conducted in the Ovid Medline, CINAHL and Cochrane Library databases. The inclusion criteria were peer-reviewed, empirical studies on the right to know with samples comprising adult patients. Data were analysed with inductive content analysis, and methodological quality was assessed with Mixed Methods Appraisal Tool.
RESULTS
Out of 2658 identified reports, 12 were selected for analysis. Based on the results, the research on patients' right to know can be classified into two main content categories: (1) expectations of the right and (2) realisation of the right. In the quality assessment, most of the reports did not meet all the quality criteria, the most common deficits being related to instrumentation and risk of bias.
CONCLUSIONS
Research-based evidence on patients' right to know provided a general insight into expectations and realisation of the right to know and not to know. The results indicate a need for continued efforts for novel approaches with high-quality methodological choices in future studies.
RELEVANCE TO CLINICAL PRACTICE
Nurses make constantly ethical decisions: The findings of this study can be useful for their decision-making and understanding of the patient's perspective on knowledge issues, and therefore, support ethically high-quality patient education.
PATIENT OR PUBLIC CONTRIBUTION
No direct patient or public contribution to the review.
Topics: Adult; Humans; Patient Rights; Access to Information
PubMed: 36550593
DOI: 10.1111/jocn.16603 -
Psychotherapy (Chicago, Ill.) Sep 2023Interpretations are a hallmark of psychodynamic treatment and a method used in other theoretical orientations as well. Therapists use interpretations to increase...
Interpretations are a hallmark of psychodynamic treatment and a method used in other theoretical orientations as well. Therapists use interpretations to increase patients' insight concerning unconscious and preconscious elements in their lives, with the ultimate aim to reduce mental pain and suffering and improve mental health. This systematic review focuses on the association between the therapists' use and accuracy of interpretation and immediate (within-session), intermediate (between-session), and distal (end-of-treatment) outcomes. This synthesis of the research literature is based on 18 independent samples of 1,011 total patients in individual psychotherapy. The results suggest that the use and accuracy of interpretations were associated, in half the studies, with patient disclosure of emotions and increased insight at the immediate, moment-to-moment enfolding of the session. At the intermediate postsession outcome, the use of interpretations was associated with a stronger alliance and greater depth, in half the studies. At the end of treatment, however, while there is some evidence for a positive effect of the use of interpretations on treatment success, there are also neutral effects and even evidence that interpretations have the potential to be harmful in some particular situations. The article concludes with training implications and therapeutic practices based on the integration of clinical experience and research evidence. (PsycInfo Database Record (c) 2023 APA, all rights reserved).
Topics: Humans; Professional-Patient Relations; Psychotherapy; Emotions; Treatment Outcome; Mental Health
PubMed: 37023282
DOI: 10.1037/pst0000479 -
Current Medical Research and Opinion Oct 2023To provide a systematic overview of bioethical debate on somatic gene therapy as documented in the scientific literature. (Review)
Review
OBJECTIVE
To provide a systematic overview of bioethical debate on somatic gene therapy as documented in the scientific literature.
METHODS
We performed a systematic review of reasons, following Strech and Sofaer approach, which is a method to systematically identify and classify arguments (reasons) used in the scientific literature. We identified 217 eligible publications retrieved from PubMed, Lilacs, PhilPapers, and Google Scholar. A meta-synthesis was performed to analyze the data.
RESULTS
We extracted 189 arguments. Arguments were grouped into 23 categories. Twelve categories were classified as research-related, including the risk/benefit ratio, priorities and limits, informed consent, review, and monitoring. Eleven were classified as society-related, including population impact, human identity, public perception, human health.
CONCLUSION
Our study provides a database of existing challenges and arguments of somatic gene therapy and may serve as the basis of normative analysis. By presenting collected arguments, we contribute to the discussion about the ethics and social dimensions of somatic gene therapy.
Topics: Humans; Bioethics; Genetic Therapy; Informed Consent
PubMed: 37772315
DOI: 10.1080/03007995.2023.2257600 -
Human Vaccines & Immunotherapeutics Dec 2023In May 2021, the Italian government extended the COVID-19 vaccination campaign to 12- to 18-year-old subjects and, starting December 2021, vaccines were also offered to... (Meta-Analysis)
Meta-Analysis
In May 2021, the Italian government extended the COVID-19 vaccination campaign to 12- to 18-year-old subjects and, starting December 2021, vaccines were also offered to children between 5 and 11 years-old. Despite these efforts, suboptimal vaccination coverages are reported. The purpose of this review is to estimate the proportion of parents/caregivers of children and adolescents expressing COVID-19 vaccine hesitancy in Italy. The vaccine hesitation rate among parents of minors was 55.1% (95%CI: 43.8-66.1%). A higher value was evidenced in studies focusing on children (59.9%; 95%CI = 43.7-75.1%) compared to the ones focusing on adolescents (51.3%; 95%CI = 34.5-68.0%). The main reasons for unwillingness were the belief that the vaccine was unsafe or ineffective, fear of adverse events, and considering COVID-19 a non-threatening disease. The implementation of effective communication campaigns and health educational programs on safe pediatric vaccinations is essential to support strategies to bolster vaccination confidence.
Topics: Adolescent; Humans; Child; Child, Preschool; COVID-19 Vaccines; Vaccination Hesitancy; COVID-19; Vaccination; Italy; Parents
PubMed: 36698309
DOI: 10.1080/21645515.2023.2171185 -
Cureus Feb 2024Health law plays a crucial role in the field of medicine, as it dictates appropriate practices, regulations, and rights and responsibilities for healthcare professionals... (Review)
Review
Health law plays a crucial role in the field of medicine, as it dictates appropriate practices, regulations, and rights and responsibilities for healthcare professionals and patients. Despite this undeniable relationship, there is a lack of focus on health law, and an outdated hidden curriculum in medical education has perpetuated long-standing negative perceptions of the legal system. PubMed was searched for articles related to medicolegal education that were published from January 1950 to December 2022. The following search terms were utilized: "(medical student) AND (law OR legal OR medico-legal) AND (education)". Literature that directly or indirectly discussed the relationship between law and medicine as well as the role of medical student education within the medicolegal nexus were reviewed. Additional literature was identified from reference lists of systematic and literature reviews. The authors manually reviewed each included publication to determine key details, study populations, and conclusions. The PubMed search revealed 3,592 papers that were sorted for relevance. Forty-four articles published between 1971 and 2022 were reviewed and analyzed. Three main themes consistently emerged from the discussions in these articles. The first theme concerns the sentiment among medical students that they were ill-prepared to manage the legal aspects of healthcare. The second theme concerns the negative perception of health law by medical students. The third theme details the benefits of including medicolegal courses in medical school curricula. This study sheds light on the notion that medical students feel ill-prepared to handle the legal aspects of healthcare due to limited medicolegal education. Furthermore, negative perceptions of the legal field continue to exist amongst medical students due to a plethora of factors, including an outdated hidden curriculum. Incorporating medicolegal courses into medical school curricula can foster positive attitudes toward the field of law and lead to enhanced professional ethics, increased patient advocacy, and potentially improved patient outcomes.
PubMed: 38505453
DOI: 10.7759/cureus.54377 -
Medicina (Kaunas, Lithuania) Oct 2023: Respectful maternity care promotes practices that acknowledge women's preferences and women and newborns' needs. It is an individual-centered strategy founded on... (Review)
Review
: Respectful maternity care promotes practices that acknowledge women's preferences and women and newborns' needs. It is an individual-centered strategy founded on ethical and human rights principles. The objective of this systematic review is to identify the impact of income on maternal care and respectful maternity care in low- and middle-income countries. : Data were searched from Google Scholar, PubMed, Web of Science, NCBI, CINAHL, National Library of Medicine, ResearchGate, MEDLINE, EMBASE database, Scopus, Cochrane Central Register of Controlled Trials (CENTRAL), and Maternity and Infant Care database. This review followed PRISMA guidelines. The initial search for publications comparing low- and middle-income countries with respectful maternity care yielded 6000 papers, from which 700 were selected. The review articles were further analyzed to ensure they were pertinent to the comparative impact of income on maternal care. A total of 24 articles were included, with preference given to those published from 2010 to 2023 during the last fourteen years. : Considering this study's findings, respectful maternity care is a crucial component of high-quality care and human rights. It can be estimated that there is a direct association between income and maternity care in LMICs, and maternity care is substandard compared to high-income countries. Moreover, it is determined that the evidence for medical tools that can enhance respectful maternity care is sparse. : This review highlights the significance of improving maternal care experiences, emphasizing the importance of promoting respectful practices and addressing disparities in low- and middle-income countries.
Topics: United States; Infant; Female; Pregnancy; Infant, Newborn; Humans; Maternal Health Services; Developing Countries; Quality of Health Care; Income; Qualitative Research
PubMed: 37893560
DOI: 10.3390/medicina59101842