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Expert Review of Pharmacoeconomics &... 2016This evaluation determines whether published studies to date meet the key characteristics identified for budget impact analyses (BIA) for medicines, accomplished through... (Review)
Review
This evaluation determines whether published studies to date meet the key characteristics identified for budget impact analyses (BIA) for medicines, accomplished through a systematic review and assessment against identified key characteristics. Studies from 2001-2015 on 'budget impact analysis' with 'drug' interventions were assessed, selected based on their titles/abstracts and full texts, and their characteristics checked according to key criteria. Out of 1,984 studies, 92 were subsequently identified for review. Of these, 95% were published in Europe and the USA. 2012 saw the largest number of publications (16%) with a decline thereafter. 48% met up to 7 out of the 9 key characteristics. Only 22% stated no conflict of interest. The results indicate low adherence to the key characteristics that should be considered for BIAs and strong conflict of interest. This is an issue since BIAs can be of fundamental importance in managing the entry of new medicines including reimbursement decisions.
Topics: Budgets; Conflict of Interest; Humans; Insurance, Pharmaceutical Services; Pharmaceutical Preparations; Reimbursement Mechanisms; Technology Assessment, Biomedical
PubMed: 26923561
DOI: 10.1586/14737167.2016.1159958 -
Adolescent Research Review 2022Adolescence is a developmentally sensitive period for emotion regulation with potentially lifelong implications for mental health and well-being. Although substantial... (Review)
Review
UNLABELLED
Adolescence is a developmentally sensitive period for emotion regulation with potentially lifelong implications for mental health and well-being. Although substantial empirical research has addressed this topic, the literature is fragmented across subdisciplines, and an overarching theoretical framework is lacking. The first step toward constructing a unifying framework is identifying relevant phenomena. This systematic review of 6305 articles used text mining to identify phenomena relevant to adolescents' emotion regulation. First, a baseline was established of relevant phenomena discussed in theory and recent narrative reviews. Then, article keywords and abstracts were analyzed using text mining, examining term frequency as an indicator of relevance and term co-occurrence as an indicator of association. The results reflected themes commonly featured in theory and narrative reviews, such as socialization and neurocognitive development, but also identified undertheorized themes, such as developmental disorders, physical health, external stressors, structural disadvantage, substance use, identity and moral development, and sexual development. The findings illustrate how text mining systematic reviews, a novel approach, may complement narrative reviews. Future theoretical work might integrate these undertheorized themes into an overarching framework, and empirical research might consider them as promising areas for future research, or as potential confounders in research on adolescents' emotion regulation.
SUPPLEMENTARY INFORMATION
The online version contains supplementary material available at 10.1007/s40894-021-00160-7.
PubMed: 34036150
DOI: 10.1007/s40894-021-00160-7 -
Maternal & Child Nutrition Jul 2021Negative maternal affect (e.g., depression and anxiety) has been associated with shorter breastfeeding duration and poorer breastfeeding intention, initiation, and... (Review)
Review
Negative maternal affect (e.g., depression and anxiety) has been associated with shorter breastfeeding duration and poorer breastfeeding intention, initiation, and exclusivity. Other affective states, including guilt and shame, have been linked with formula feeding practice, though existing literature has yet to be synthesised. A narrative synthesis of quantitative data and a framework synthesis of qualitative and quantitative data were conducted to explore guilt and/or shame in relation to infant feeding outcomes. Searches were conducted on the DISCOVER database between December 2017 and March 2018. The search strategy was rerun in February 2020, together yielding 467 studies. The study selection process identified 20 articles, published between 1997 and 2017. Quantitative results demonstrated formula feeders experienced guilt more commonly than breastfeeding mothers. Formula feeders experienced external guilt most commonly associated with healthcare professionals, whereas breastfeeding mothers experienced guilt most commonly associated with peers and family. No quantitative literature examined shame in relation to infant feeding outcomes, warranting future research. The framework synthesis generated four distinct themes which explored guilt and/or shame in relation to infant feeding outcomes: 'underprepared and ineffectively supported', 'morality and perceived judgement' (breastfeeding), 'frustration with infant feeding care' and 'failures, fears and forbidden practice' (formula feeding). Both guilt and shame were associated with self-perception as a bad mother and poorer maternal mental health. Guilt and shame experiences were qualitatively different in terms of sources and outcomes, dependent on infant feeding method. Suggestions for tailored care to minimise guilt and shame, while supporting breastfeeding, are provided.
Topics: Breast Feeding; Female; Guilt; Humans; Infant; Mothers; Postpartum Period; Shame
PubMed: 33491303
DOI: 10.1111/mcn.13141 -
BMC Medical Education Jan 2021Teaching cybercivility requires thoughtful attention to curriculum development and content delivery. Theories, models, and conceptual and theoretical frameworks... (Review)
Review
BACKGROUND
Teaching cybercivility requires thoughtful attention to curriculum development and content delivery. Theories, models, and conceptual and theoretical frameworks (hereafter "tools") provide useful foundations for integrating new knowledge and skills into existing professional practice and education. We conducted this scoping review to identify tools used for teaching cybercivility in health professions education.
METHODS
Using Arksey and O'Malley's scoping review framework, we searched six biomedical and educational databases and three grey literature databases for articles available in English published between January 1, 2000 and March 31, 2020. Following the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews), we screened and extracted relevant data, and reported the results of the search.
RESULTS
The search resulted in 2272 articles, with 8 articles included in this review after inclusion criteria were applied. Four articles (50%) were peer-reviewed journal papers while the other 4 (50%) were dissertations. Eleven unique tools were identified by this review: (1) Transpersonal Caring Theory, (2) Theory of Workplace Incivility, (3) Conceptualization of Incivility, (4) Media Ecology Theory, (5) Principlism, (6) Salmon's Five Stage Model of Online Learning, (7) Learner-Centered Educational Theory, (8) Gallant and Drinan's 4-Stage Model of Institutionalization of Academic Integrity, (9) Theory of Planned Behavior, (10) Communication Privacy Management Theory, and (11) Moral Development Theory. Based on the tools analyzed in our scoping review, we determined three features of cybercivility pedagogy to which the tools provided a guide: (1) behavioral manifestations, (2) academic integrity, and (3) digital professionalism.
CONCLUSIONS
The reviewed tools provide a pedagogical foundation and guidance for teaching various properties of cybercivility. Future studies should be expanded to include a broader literature body and non-English literature to provide the global perspective and global skills needed by a diverse population of learners.
Topics: Communication; Delivery of Health Care; Health Occupations; Professionalism; Thinking
PubMed: 33516204
DOI: 10.1186/s12909-021-02507-z -
Systematic Reviews Mar 2021The nature and existence of free will have been debated for centuries. Since some psychiatric disorders are known to interfere with one's ability to control their... (Review)
Review
BACKGROUND
The nature and existence of free will have been debated for centuries. Since some psychiatric disorders are known to interfere with one's ability to control their actions and thoughts (e.g., schizophrenia), the investigation of the psychiatric facet of free will beliefs seems to be relevant. In this systematic review, we were interested in clarifying if and how having a mental disorder affects individuals' beliefs in free will by comparing psychiatric vs. non-psychiatric samples.
METHODS
A systematic search of MEDLINE, Web of Science, EMBASE, and PsycINFO databases was performed between 04 and 09 November 2020. The search strategy included "free will" and related constructs and terms related to DSM-5 mental disorders characterized by psychotic, compulsive, avoidant, or impulsive symptoms. Eligible designs of studies included case-control and cohort studies. Study selection took place in committee meetings consisting of six researchers. Quality assessment of the selected studies was performed through the Joanna Briggs Institute Appraisal Checklist for Case Control Studies.
RESULTS
After removing duplicates, a total of 12,218 titles/abstracts were screened. Inclusion and exclusion criteria were followed, and three articles were eventually selected.
CONCLUSIONS
It is not possible to provide unequivocal confirmation that having a mental disorder can or cannot affect someone's belief in free will. Studies with different mental disorders should be conducted in this field.
SYSTEMATIC REVIEW REGISTRATION
PROSPERO CRD42018109468.
Topics: Case-Control Studies; Humans; Mental Disorders; Personal Autonomy
PubMed: 33726858
DOI: 10.1186/s13643-021-01621-9 -
BMC Medicine Oct 2016Modern standards for evidence-based decision making in clinical care and public health still rely solely on eminence-based input when it comes to normative ethical... (Review)
Review
BACKGROUND
Modern standards for evidence-based decision making in clinical care and public health still rely solely on eminence-based input when it comes to normative ethical considerations. Manuals for clinical guideline development or health technology assessment (HTA) do not explain how to search, analyze, and synthesize relevant normative information in a systematic and transparent manner. In the scientific literature, however, systematic or semi-systematic reviews of ethics literature already exist, and scholarly debate on their opportunities and limitations has recently bloomed.
METHODS
A systematic review was performed of all existing systematic or semi-systematic reviews for normative ethics literature on medical topics. The study further assessed how these reviews report on their methods for search, selection, analysis, and synthesis of ethics literature.
RESULTS
We identified 84 reviews published between 1997 and 2015 in 65 different journals and demonstrated an increasing publication rate for this type of review. While most reviews reported on different aspects of search and selection methods, reporting was much less explicit for aspects of analysis and synthesis methods: 31 % did not fulfill any criteria related to the reporting of analysis methods; for example, only 25 % of the reviews reported the ethical approach needed to analyze and synthesize normative information.
CONCLUSIONS
While reviews of ethics literature are increasingly published, their reporting quality for analysis and synthesis of normative information should be improved. Guiding questions are: What was the applied ethical approach and technical procedure for identifying and extracting the relevant normative information units? What method and procedure was employed for synthesizing normative information? Experts and stakeholders from bioethics, HTA, guideline development, health care professionals, and patient organizations should work together to further develop this area of evidence-based health care.
Topics: Clinical Competence; Decision Making; Ethics, Clinical; Evidence-Based Medicine; Humans; Morals; Public Health; Public Policy; Technology Assessment, Biomedical
PubMed: 27716264
DOI: 10.1186/s12916-016-0688-1 -
The Cochrane Database of Systematic... Jul 2019Decisions in clinical medicine can be associated with ethical challenges. Ethical case interventions (e.g. ethics committee, moral case deliberation) identify and... (Review)
Review
BACKGROUND
Decisions in clinical medicine can be associated with ethical challenges. Ethical case interventions (e.g. ethics committee, moral case deliberation) identify and analyse ethical conflicts which occur within the context of care for patients. Ethical case interventions involve ethical experts, different health professionals as well as the patient and his/her family. The aim is to support decision-making in clinical practice. This systematic review gathered and critically appraised the available evidence of controlled studies on the effectiveness of ethical case interventions.
OBJECTIVES
To determine whether ethical case interventions result in reduced decisional conflict or moral distress of those affected by an ethical conflict in clinical practice; improved patient involvement in decision-making and a higher quality of life in adult patients. To determine the most effective models of ethical case interventions and to analyse the use and appropriateness of the outcomes in experimental studies.
SEARCH METHODS
We searched the following electronic databases for primary studies to September 2018: CENTRAL, MEDLINE, Embase, CINAHL and PsycINFO. We also searched CDSR and DARE for related reviews. Furthermore, we searched Clinicaltrials.gov, International Clinical Trials Registry Platform Search Portal and conducted a cited reference search for all included studies in ISI WEB of Science. We also searched the references of the included studies.
SELECTION CRITERIA
We included randomised trials, non-randomised trials, controlled before-after studies and interrupted time series studies which compared ethical case interventions with usual care or an active control in any language. The included population were adult patients. However, studies with mixed populations consisting of adults and children were included, if a subgroup or sensitivity analysis (or both) was performed for the adult population.
DATA COLLECTION AND ANALYSIS
We used standard methodological procedures expected by Cochrane and the Effective Practice and Organisation of Care review group. We used meta-analysis based on a random-effects model for treatment costs and structured analysis for the remaining outcomes, because these were heterogeneously reported. We used the GRADE approach to assess the certainty of the evidence.
MAIN RESULTS
We included four randomised trials published in six articles. The publication dates ranged from 2000 to 2014. Three studies were conducted in the USA, and one study in Taiwan. All studies were conducted on intensive care units and included 1165 patients. We judged the included studies to be of moderate or high risk of bias. It was not possible to compare different models of the intervention regarding effectiveness due to the diverse character of the interventions and the small number of studies. Included studies did not directly measure the main outcomes. All studies received public funding and one received additional funding from private sources.We identified two models of ethical case interventions: proactive and request-based ethics consultation. Three studies evaluated proactive ethics consultation (n = 1103) of which one study reported findings on one key outcome criterion. The studies did not report data on decisional conflict, moral distress of participants of ethical case interventions, patient involvement in decision-making, quality of life or ethical competency for proactive ethics consultation. One study assessed satisfaction with care on a 5-point Likert scale (1 = lowest rating, 5 = highest rating). The healthcare providers (nurses and physicians, n = 365) scored a value of 4 or 5 for 81.4% in the control group and 86.1% in the intervention group (P > 0.05). The patients or their surrogates (n = 275) scored a value of 4 or 5 for 83.6% in the control group and for 74.8% in the intervention group (P > 0.05). It was uncertain whether proactive ethics consultation led to high satisfaction with care, because the certainty of evidence was very low.One study evaluated request-based ethics consultation (n = 62). The study indirectly measured decisional conflict by assessing consensus regarding patient care. The risk (increase in consensus, reduction in decisional conflict) increased by 80% as a result of the intervention. The risk ratio was 0.20 (95% confidence interval 0.09 to 0.46; P < 0.01). It was uncertain whether request-based ethics consultation reduced decisional conflict, because the certainty of evidence was very low. The study did not report data on moral distress of participants of ethical case interventions, patient involvement in decision-making, quality of life, or ethical competency or satisfaction with care for request-based ethics consultation.
AUTHORS' CONCLUSIONS
It is not possible to determine the effectiveness of ethical case interventions with certainty due to the low certainty of the evidence of included studies in this review. The effectiveness of ethical case interventions should be investigated in light of the outcomes reported in this systematic review. In addition, there is need for further research to identify and measure outcomes which reflect the goals of different types of ethical case intervention.
PubMed: 31424106
DOI: 10.1002/14651858.CD012636.pub2 -
PloS One 2017Over the last three decades, various instruments were developed and employed to assess medical professionalism, but their measurement properties have yet to be fully... (Review)
Review
BACKGROUND
Over the last three decades, various instruments were developed and employed to assess medical professionalism, but their measurement properties have yet to be fully evaluated. This study aimed to systematically evaluate these instruments' measurement properties and the methodological quality of their related studies within a universally acceptable standardized framework and then provide corresponding recommendations.
METHODS
A systematic search of the electronic databases PubMed, Web of Science, and PsycINFO was conducted to collect studies published from 1990-2015. After screening titles, abstracts, and full texts for eligibility, the articles included in this study were classified according to their respective instrument's usage. A two-phase assessment was conducted: 1) methodological quality was assessed by following the COnsensus-based Standards for the selection of health status Measurement INstruments (COSMIN) checklist; and 2) the quality of measurement properties was assessed according to Terwee's criteria. Results were integrated using best-evidence synthesis to look for recommendable instruments.
RESULTS
After screening 2,959 records, 74 instruments from 80 existing studies were included. The overall methodological quality of these studies was unsatisfactory, with reasons including but not limited to unknown missing data, inadequate sample sizes, and vague hypotheses. Content validity, cross-cultural validity, and criterion validity were either unreported or negative ratings in most studies. Based on best-evidence synthesis, three instruments were recommended: Hisar's instrument for nursing students, Nurse Practitioners' Roles and Competencies Scale, and Perceived Faculty Competency Inventory.
CONCLUSION
Although instruments measuring medical professionalism are diverse, only a limited number of studies were methodologically sound. Future studies should give priority to systematically improving the performance of existing instruments and to longitudinal studies.
Topics: Attitude of Health Personnel; Health Status; Humans; Professionalism
PubMed: 28498838
DOI: 10.1371/journal.pone.0177321 -
JMIR Human Factors Dec 2023Humans currently dominate decision-making in both clinical health services and complex health services such as health policy and health regulation. Many assumptions... (Review)
Review
BACKGROUND
Humans currently dominate decision-making in both clinical health services and complex health services such as health policy and health regulation. Many assumptions inherent in health service models today are underpinned by Ramsey's Expected Utility Theory, a prominent theory in the field of economics that is rooted in rationality. Rational, evidence-based metrics currently dominate the culture of decision-making in health policy and regulation. However, as the COVID-19 pandemic has shown, rational metrics alone may not suffice in making better policy and regulatory decisions. There are ethical and moral considerations and other complex factors that cannot be reduced to evidence-based rationality alone. Therefore, this scoping review was undertaken to identify and map the attributes that influence human decision-making in complex health services.
OBJECTIVE
The objective is to identify and map the attributes that influence human decision-making in complex health services that have been reported in the peer-reviewed literature.
METHODS
This scoping review was designed to answer the following research question: what attributes have been reported in the literature that influence human decision-making in complex health services? A clear, reproducible methodology is provided. It is reported in accordance with the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews) standards and a recognized framework. As the topic of interest merited broad review to scope and understand literature from a holistic viewpoint, a scoping review of literature was appropriate here. Inclusion and exclusion criteria were developed, and a database search undertaken within 4 search systems-ProQuest, Scopus, PubMed, and Web of Science.
RESULTS
The results span 46 years, from 1976 to 2022. A total of 167 papers were identified. After removing duplicates, 81 papers remained. Of these, 77 papers were excluded based on the inclusion and exclusion criteria. The remaining 4 papers were found to be relevant. Citation tracking was undertaken, identifying 4 more relevant papers. Thus, a total of 8 papers were included. These papers were reviewed in detail to identify the human attributes mentioned and count the frequency of mentions. A thematic analysis was conducted to identify the themes.
CONCLUSIONS
The results highlight key themes that underline the complex and nuanced nature of human decision-making. The results suggest that rationality is entrenched and may influence the lexicon of our thinking about decision-making. The results also highlight the counter narrative of decision-making underpinned by uniquely human attributes. This may have ramifications for decision-making in complex health services today. The review itself takes a rational approach, and the methods used were suited to this.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
RR2-10.2196/42353.
Topics: Humans; Pandemics; Benchmarking; COVID-19; Health Policy; Health Services
PubMed: 38117553
DOI: 10.2196/46490 -
The Cochrane Database of Systematic... Oct 2017Fibromyalgia (FM) is a clinically well-defined chronic condition of unknown aetiology characterised by chronic widespread pain that often co-exists with sleep problems... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Fibromyalgia (FM) is a clinically well-defined chronic condition of unknown aetiology characterised by chronic widespread pain that often co-exists with sleep problems and fatigue. People often report high disability levels and poor health-related quality of life (HRQoL). Drug therapy focuses on reducing key symptoms and disability, and improving HRQoL. Anticonvulsants (antiepileptic drugs) are drugs frequently used for the treatment of chronic pain syndromes.
OBJECTIVES
To assess the benefits and harms of anticonvulsants for treating FM symptoms.
SEARCH METHODS
We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (Issue 8, 2013), MEDLINE (1966 to August 2013), PsycINFO (1966 to August 2013), SCOPUS (1980 to August 2013) and the reference lists of reviewed articles for published studies and www.clinicaltrials.gov (to August 2013) for unpublished trials.
SELECTION CRITERIA
We selected randomised controlled trials of any formulation of anticonvulsants used for the treatment of people with FM of any age.
DATA COLLECTION AND ANALYSIS
Two review authors independently extracted the data of all included studies and assessed the risks of bias of the studies. We resolved discrepancies by discussion.
MAIN RESULTS
We included eight studies: five with pregabalin and one study each with gabapentin, lacosamide and levetiracetam. A total of 2480 people were included into anticonvulsants groups and 1099 people in placebo groups. The median therapy phase of the studies was 13 weeks. The amount and quality of evidence were insufficient to draw definite conclusions on the efficacy and safety of gabapentin, lacosamide and levetiracetam in FM. The amount and quality of evidence was sufficient to draw definite conclusions on the efficacy and safety of pregabalin in FM. Therefore, we focused on our interpretation of the evidence for pregabalin due to our greater certainty about its effects and its greater relevance to clinical practice. All pregabalin studies had a low risk of bias. Reporting a 50% or greater reduction in pain was more frequent with pregabalin use than with a placebo (risk ratio (RR) 1.59; 95% confidence interval (CI) 1.33 to 1.90; number needed to treat for an additional beneficial outcome (NNTB) 12; 95% CI 9 to 21). The number of people who reported being 'much' or 'very much' improved was higher with pregabalin than with placebo (RR 1.38; 95% CI 1.23 to 1.55; NNTB 9; 95% CI 7 to 15). Pregabalin did not substantially reduce fatigue (SMD -0.17; 95% CI -0.25 to -0.09; 2.7% absolute improvement on a 1 to 50 scale) compared with placebo. Pregabalin had a small benefit over placebo in reducing sleep problems by 6.2% fewer points on a scale of 0 to 100 (standardised mean difference (SMD) -0.35; 95% CI -0.43 to -0.27). The dropout rate due to adverse events was higher with pregabalin use than with placebo use (RR 1.68; 95% CI 1.36 to 2.07; number needed to treat for an additional harmful outcome (NNTH) 13; 95% CI 9 to 23). There was no significant difference in serious adverse events between pregabalin and placebo use (RR 1.03; 95% CI 0.71 to 1.49). Dizziness was reported as an adverse event more frequently with pregabalin use than with placebo use (RR 3.77; 95% CI 3.06 to 4.63; NNTH 4; 95% CI 3 to 5).
AUTHORS' CONCLUSIONS
The anticonvulsant, pregabalin, demonstrated a small benefit over placebo in reducing pain and sleep problems. Pregabalin use was shown not to substantially reduce fatigue compared with placebo. Study dropout rates due to adverse events were higher with pregabalin use compared with placebo. Dizziness was a particularly frequent adverse event seen with pregabalin use. At the time of writing this review, pregabalin is the only anticonvulsant drug approved for treating FM in the US and in 25 other non-European countries. However, pregabalin has not been approved for treating FM in Europe. The amount and quality of evidence were insufficient to draw definite conclusions on the efficacy and safety of gabapentin, lacosamide and levetiracetam in FM.
Topics: Acetamides; Amines; Anticonvulsants; Conflict of Interest; Cyclohexanecarboxylic Acids; Fibromyalgia; Gabapentin; Humans; Lacosamide; Levetiracetam; Piracetam; Pregabalin; gamma-Aminobutyric Acid
PubMed: 28991361
DOI: 10.1002/14651858.CD010782.pub2