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Frontiers in Pharmacology 2021Accessibility of medicines for children is a matter of global concern. Medicines prescribed for children are often off-label. To formulate appropriate policies and...
Accessibility of medicines for children is a matter of global concern. Medicines prescribed for children are often off-label. To formulate appropriate policies and undertake necessary interventions to improve access to medicines for children, it is necessary to evaluate the accessibility of medicines for children. However, there is no systematic review of the medicine accessibility for children. Relevant studies were identified through searching Pubmed, Embase, CNKI, Wanfang, VIP, World Health Organization website, and Health Action International website. Besides, the references of included studies as a supplementary search were read. We extracted the basic information of articles (the first author, published year, the name of journal, research institution, etc.), the basic study characteristics (survey area, survey time, survey method, survey medicine lists, the number of medicine outlets surveyed, etc.), and the study results (the current situation of the accessibility of medicines for children, including the availability, price, and affordability of medicines for children, etc.). Two reviewers independently selected studies and extracted the data. Descriptive analysis methods to analyze the current situation of the accessibility of children's medicines were used. A total of 18 multicenter cross-sectional studies were included in this systematic review, which were from low-income and middle-income countries. Seventeen studies (17/18, 94.4%) used the WHO/Health Action International (HAI) medicine price methodology to investigate the accessibility of medicines for children. Fifteen studies (15/18, 83.3%) were selected to investigate medicines based on the WHO Model List of Essential Medicines for Children (WHO EMLc). In the public sectors, the availability of originator brands (OBs) ranged from 0 to 52.0%, with a median of 24.2%, and the availability of lowest-priced generics (LPGs) ranged from 17.0 to 72.6%, with a median of 38.1%. In the private sectors, the availability of OBs ranged from 8.9 to 80%, with a median of 21.2%. The availability of LPGs ranged from 20.6 to 72.2%, with a median of 35.9%. In most regions, the availability of OBs in the private sectors was higher than in the public sectors. Collectively, in the price of medicines for children, the median price ratio (MPR) of the OBs in the public sectors and private sectors were much higher than that of the LPGs. And the affordability of the LPGs in the public sectors and private sectors was higher than that of originator brands (OBs). The availability of medicines for children is low in both the public sectors and private sectors in low-income and middle-income countries. The MPR of originator brands (OBs) is higher than that of lowest-priced generics (LPGs), and the most lowest-priced generics (LPGs) have better affordability.
PubMed: 34421594
DOI: 10.3389/fphar.2021.691606 -
Implementation Science : IS Feb 2020Application of knowledge translation (KT) theories, models, and frameworks (TMFs) is one method for successfully incorporating evidence into clinical care. However,...
BACKGROUND
Application of knowledge translation (KT) theories, models, and frameworks (TMFs) is one method for successfully incorporating evidence into clinical care. However, there are multiple KT TMFs and little guidance on which to select. This study sought to identify and describe available full-spectrum KT TMFs to subsequently guide users.
METHODS
A scoping review was completed. Articles were identified through searches within electronic databases, previous reviews, grey literature, and consultation with KT experts. Search terms included combinations of KT terms and theory-related terms. Included citations had to describe full-spectrum KT TMFs that had been applied or tested. Titles/abstracts and full-text articles were screened independently by two investigators. Each KT TMF was described by its characteristics including name, context, key components, how it was used, primary target audience, levels of use, and study outcomes. Each KT TMF was also categorized into theoretical approaches as process models, determinant frameworks, classic theories, implementation theories, and evaluation frameworks. Within each category, KT TMFs were compared and contrasted to identify similarities and unique characteristics.
RESULTS
Electronic searches yielded 7160 citations. Additional citations were identified from previous reviews (n = 41) and bibliographies of included full-text articles (n = 6). Thirty-six citations describing 36 full-spectrum were identified. In 24 KT TMFs, the primary target audience was multi-level including patients/public, professionals, organizational, and financial/regulatory. The majority of the KT TMFs were used within public health, followed by research (organizational, translation, health), or in multiple contexts. Twenty-six could be used at the individual, organization, or policy levels, five at the individual/organization levels, three at the individual level only, and two at the organizational/policy level. Categorization of the KT TMFs resulted in 18 process models, eight classic theories, three determinant frameworks, three evaluation frameworks, and four that fit more than one category. There were no KT TMFs that fit the implementation theory category. Within each category, similarities and unique characteristics emerged through comparison.
CONCLUSIONS
A systematic compilation of existing full-spectrum KT TMFs, categorization into different approaches, and comparison has been provided in a user-friendly way. This list provides options for users to select from when designing KT projects and interventions.
TRIAL REGISTRATION
A protocol outlining the methodology of this scoping review was developed and registered with PROSPERO (CRD42018088564).
Topics: Delivery of Health Care; Humans; Models, Organizational; Research Design; Translational Research, Biomedical
PubMed: 32059738
DOI: 10.1186/s13012-020-0964-5 -
Medicina (Kaunas, Lithuania) Mar 2023Human histology provides critical information on the biological potential of various regenerative protocols and biomaterials, which is vital to advancing the field of... (Review)
Review
Human histology provides critical information on the biological potential of various regenerative protocols and biomaterials, which is vital to advancing the field of periodontal regeneration, both in research and clinical practice. Outcomes of histologic studies are particularly valuable when interpreted considering additional evidence available from pre-clinical and clinical studies. One of the best-documented growth factors areproven to have positive effects on a myriad of oral regenerative procedures is recombinant human platelet-derived growth factor-BB (rhPDGF-BB). While a systematic review of clinical studies evaluating rhPDGF in oral regenerative procedures has been recently completed, a review article that focuses on the histologic outcomes is needed. Hence, this communication discusses the histologic effects of rhPDGF-BB on oral and periodontal regenerative procedures, including root coverage and soft tissue augmentation, intrabony defects, furcation defects, peri-implant bone augmentation, and guided bone regeneration. Studies from 1989 to 2022 have been included in this review.
Topics: Humans; Becaplermin; Proto-Oncogene Proteins c-sis; Recombinant Proteins; Intercellular Signaling Peptides and Proteins; Furcation Defects
PubMed: 37109634
DOI: 10.3390/medicina59040676 -
Journal of Geriatric Oncology Jun 2023The number of older patients with cancer is expected to continue to increase owing to the aging population. Recently, the usefulness of geriatric assessment (GA)... (Review)
Review
Significance of the comprehensive geriatric assessment in the administration of chemotherapy to older adults with cancer: Recommendations by the Japanese Geriatric Oncology Guideline Committee.
INTRODUCTION
The number of older patients with cancer is expected to continue to increase owing to the aging population. Recently, the usefulness of geriatric assessment (GA) conducted by multiple staff members from different medical backgrounds has been reported; however, a consensus on the effectiveness of GA has not yet been achieved.
MATERIALS AND METHODS
We, as the Japanese Geriatric Oncology Guideline Committee for elderly patients with cancer, conducted a literature search of randomized controlled trials published before August 2021 that used GA or comprehensive GA (CGA) as an intervention for patients with cancer undergoing chemotherapy. As the key outcomes for answering the clinical question, we focused on survival benefit, adverse events, and quality of life (QOL). After a systematic review of these studies, the expert panel member developed recommendations according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system.
RESULTS
For older patients with cancer, GA or CGA is suggested during or before chemotherapy (weakly recommended). Chemotherapy-induced adverse events were significantly reduced by GA/CGA interventions without any adverse effects on survival. Health-related QOL tended to improve with the GA/CGA interventions.
DISCUSSION
Although, in our opinion, GA/CGA does require time and resources, it poses no harm patients. Therefore, we suggest expanding the human resources and educating skills of medical providers for clinical implementation of GA/CGA.
Topics: Aged; Humans; Aging; East Asian People; Geriatric Assessment; Neoplasms; Quality of Life; Randomized Controlled Trials as Topic
PubMed: 37062639
DOI: 10.1016/j.jgo.2023.101485 -
Laryngoscope Investigative... Dec 2020The study systematically reviewed the existing literature on the management of autoimmune inner ear disease (AIED). (Review)
Review
OBJECTIVES
The study systematically reviewed the existing literature on the management of autoimmune inner ear disease (AIED).
STUDY DESIGN
Systematic review.
METHODS
We performed a literature search of Embase, NCBI, Cochrane, and Web of Science databases from April 1990 to April 2020. Inclusion criteria included studies that were retrospective or prospective in nature evaluating the treatment of AIED with audiometric data measuring hearing outcomes during treatment. Hearing improvement was the primary study outcome and improvement in vestibular symptoms was the secondary study outcome.
RESULTS
Sixteen of 412 candidate articles were included in our study. Systemic steroid treatment is most commonly described. Alternative treatment modalities included intratympanic steroid treatment, methotrexate, cyclophosphamide, azathioprine, infliximab, etanercept, adalimumab, golimumab, methylprednisolone, rituximab, and anakinra.
CONCLUSION
Systemic corticosteroids are the first line treatment of AIED. Intratympanic steroids are a potential adjuvant or alternative treatment for patients who cannot tolerate or become refractory to steroid treatment. Steroid nonresponders may benefit from biologic therapy. Alternative treatment modalities including nonsteroidal immunosuppressants and biologics have been studied in small cohorts of patients with varying results. Prospective studies investigating the efficacy of biologic and nonsteroidal therapy are warranted.
LEVEL OF EVIDENCE
2.
PubMed: 33364414
DOI: 10.1002/lio2.508 -
The Cochrane Database of Systematic... Apr 2017Tobacco use is the largest single preventable cause of death and disease worldwide. Standardised tobacco packaging is an intervention intended to reduce the promotional... (Review)
Review
BACKGROUND
Tobacco use is the largest single preventable cause of death and disease worldwide. Standardised tobacco packaging is an intervention intended to reduce the promotional appeal of packs and can be defined as packaging with a uniform colour (and in some cases shape and size) with no logos or branding, apart from health warnings and other government-mandated information, and the brand name in a prescribed uniform font, colour and size. Australia was the first country to implement standardised tobacco packaging between October and December 2012, France implemented standardised tobacco packaging on 1 January 2017 and several other countries are implementing, or intending to implement, standardised tobacco packaging.
OBJECTIVES
To assess the effect of standardised tobacco packaging on tobacco use uptake, cessation and reduction.
SEARCH METHODS
We searched MEDLINE, Embase, PsycINFO and six other databases from 1980 to January 2016. We checked bibliographies and contacted study authors to identify additional peer-reviewed studies.
SELECTION CRITERIA
Primary outcomes included changes in tobacco use prevalence incorporating tobacco use uptake, cessation, consumption and relapse prevention. Secondary outcomes covered intermediate outcomes that can be measured and are relevant to tobacco use uptake, cessation or reduction. We considered multiple study designs: randomised controlled trials, quasi-experimental and experimental studies, observational cross-sectional and cohort studies. The review focused on all populations and people of any age; to be included, studies had to be published in peer-reviewed journals. We examined studies that assessed the impact of changes in tobacco packaging such as colour, design, size and type of health warnings on the packs in relation to branded packaging. In experiments, the control condition was branded tobacco packaging but could include variations of standardised packaging.
DATA COLLECTION AND ANALYSIS
Screening and data extraction followed standard Cochrane methods. We used different 'Risk of bias' domains for different study types. We have summarised findings narratively.
MAIN RESULTS
Fifty-one studies met our inclusion criteria, involving approximately 800,000 participants. The studies included were diverse, including observational studies, between- and within-participant experimental studies, cohort and cross-sectional studies, and time-series analyses. Few studies assessed behavioural outcomes in youth and non-smokers. Five studies assessed the primary outcomes: one observational study assessed smoking prevalence among 700,000 participants until one year after standardised packaging in Australia; four studies assessed consumption in 9394 participants, including a series of Australian national cross-sectional surveys of 8811 current smokers, in addition to three smaller studies. No studies assessed uptake, cessation, or relapse prevention. Two studies assessed quit attempts. Twenty studies examined other behavioural outcomes and 45 studies examined non-behavioural outcomes (e.g. appeal, perceptions of harm). In line with the challenges inherent in evaluating standardised tobacco packaging, a number of methodological imitations were apparent in the included studies and overall we judged most studies to be at high or unclear risk of bias in at least one domain. The one included study assessing the impact of standardised tobacco packaging on smoking prevalence in Australia found a 3.7% reduction in odds when comparing before to after the packaging change, or a 0.5 percentage point drop in smoking prevalence, when adjusting for confounders. Confidence in this finding is limited, due to the nature of the evidence available, and is therefore rated low by GRADE standards. Findings were mixed amongst the four studies assessing consumption, with some studies finding no difference and some studies finding evidence of a decrease; certainty in this outcome was rated very low by GRADE standards due to the limitations in study design. One national study of Australian adult smoker cohorts (5441 participants) found that quit attempts increased from 20.2% prior to the introduction of standardised packaging to 26.6% one year post-implementation. A second study of calls to quitlines provides indirect support for this finding, with a 78% increase observed in the number of calls after the implementation of standardised packaging. Here again, certainty is low. Studies of other behavioural outcomes found evidence of increased avoidance behaviours when using standardised packs, reduced demand for standardised packs and reduced craving. Evidence from studies measuring eye-tracking showed increased visual attention to health warnings on standardised compared to branded packs. Corroborative evidence for the latter finding came from studies assessing non-behavioural outcomes, which in general found greater warning salience when viewing standardised, than branded packs. There was mixed evidence for quitting cognitions, whereas findings with youth generally pointed towards standardised packs being less likely to motivate smoking initiation than branded packs. We found the most consistent evidence for appeal, with standardised packs rating lower than branded packs. Tobacco in standardised packs was also generally perceived as worse-tasting and lower quality than tobacco in branded packs. Standardised packaging also appeared to reduce misperceptions that some cigarettes are less harmful than others, but only when dark colours were used for the uniform colour of the pack.
AUTHORS' CONCLUSIONS
The available evidence suggests that standardised packaging may reduce smoking prevalence. Only one country had implemented standardised packaging at the time of this review, so evidence comes from one large observational study that provides evidence for this effect. A reduction in smoking behaviour is supported by routinely collected data by the Australian government. Data on the effects of standardised packaging on non-behavioural outcomes (e.g. appeal) are clearer and provide plausible mechanisms of effect consistent with the observed decline in prevalence. As standardised packaging is implemented in different countries, research programmes should be initiated to capture long term effects on tobacco use prevalence, behaviour, and uptake. We did not find any evidence suggesting standardised packaging may increase tobacco use.
Topics: Humans; Prevalence; Product Labeling; Product Packaging; Smoking; Smoking Cessation; Smoking Prevention; Tobacco Use
PubMed: 28447363
DOI: 10.1002/14651858.CD011244.pub2 -
BMJ Open Sep 2017The regulation of surgical implants is vital to patient safety, and there is an international drive to establish registries for all implants. Hearing loss is an area of... (Review)
Review
OBJECTIVE
The regulation of surgical implants is vital to patient safety, and there is an international drive to establish registries for all implants. Hearing loss is an area of unmet need, and industry is targeting this field with a growing range of surgically implanted hearing devices. Currently, there is no comprehensive UK registry capturing data on these devices; in its absence, it is difficult to monitor safety, practices and effectiveness. A solution is developing a national registry of all auditory implants. However, developing and maintaining a registry faces considerable challenges. In this systematic review, we aimed to identify the essential features of a successful surgical registry.
METHODS
A systematic literature review was performed adhering to Preferred Reporting Items for Systematic Review and Meta-Analysis recommendations. A comprehensive search of the Medline and Embase databases was conducted in November 2016 using the Ovid Portal. Inclusion criteria were: publications describing the design, development, critical analysis or current status of a national surgical registry. All registry names identified in the screening process were noted and searched in the grey literature. Available national registry reports were reviewed from registry websites. Data were extracted using a data extraction table developed by thematic analysis. Extracted data were synthesised into a structured narrative.
RESULTS
Sixty-nine publications were included. The fundamentals to successful registry development include: steering committee to lead and oversee the registry; clear registry objectives; planning for initial and long-term funding; strategic national collaborations among key stakeholders; dedicated registry management team; consensus meetings to agree registry dataset; established data processing systems; anticipating challenges; and implementing strategies to increase data completion. Patient involvement and awareness of legal factors should occur throughout the development process.
CONCLUSIONS
This systematic review provides robust knowledge that can be used to inform the successful development of any UK surgical registry. It also provides a methodological framework for international surgical registry development.
Topics: Cooperative Behavior; Equipment and Supplies; Humans; Patient Safety; Prostheses and Implants; Quality Control; Registries
PubMed: 28947457
DOI: 10.1136/bmjopen-2017-017373 -
Journal of Managed Care & Specialty... Mar 2018Generic drugs are bioequivalent and cost-effective alternatives to brand drugs. In 2014, $254 billion was saved because of the use of generic drugs in the United States. (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Generic drugs are bioequivalent and cost-effective alternatives to brand drugs. In 2014, $254 billion was saved because of the use of generic drugs in the United States.
OBJECTIVE
To critically assess evidence on the association between patient characteristics and generic drug use in order to inform the development of educational outreach for improving generic drug use among patients.
METHODS
We systematically searched the literature between January 2005 and December 2016 using PubMed, Web of Science, Ovid MEDLINE, Google Scholar, and EBSCO IPA-MEDLINE for potentially relevant studies. The titles and abstracts of identified articles were assessed independently by 2 reviewers. Titles and abstracts that were not written in English, were published before 2005, were not empirical, did not contain sociodemographic data, or were not policy or methodologically relevant to generic drug use were excluded. Data were pooled in a meta-analysis using the RStudio software to assess the association of patient-related factors with generic drug use.
RESULTS
Our searches resulted in 11 articles on patient-level factors, and 6 of these articles had sufficient information to conduct meta-analyses in the domains of patients' gender, age, race/ethnicity, and income. Quantitative analysis indicated that no differences in generic drug use existed between subgroups of patients defined by gender, age, or race/ethnicity. However, patients with lower income (i.e., < 200% federal poverty level [FPL]) were more likely to use generic drugs than those with higher income (≥ 200% FPL; pooled OR = 1.32, 95% CI = 1.15-1.52). Heterogeneity was high (I > 75%) for all analyses but income.
CONCLUSIONS
Patients with lower income were more likely to use generic drugs, whereas evidence was heterogeneous regarding an association between generic drug use and gender, age, or race/ethnicity. Educational outreach targeting patients with higher incomes to understand their perspectives in generic drugs may help improve generic drug use within that population.
DISCLOSURES
Funding for this study was made possible, in part, by the U.S. Food and Drug Administration through grant U01FD005486. Hansen has provided expert testimony for Daiichi Sankyo. No other authors have declared a potential conflict of interest. Views expressed in written materials or publications and by speakers do not necessarily reflect the official policies of the U.S. Department of Health and Human Services, nor does any mention of trade names, commercial practices, or organization imply endorsement by the U.S. government. Study concept and design were contributed by Howard, Harris, Kiptanui, Hansen, and Qian. Frank, Mishuk, Howard, Harris, and Kiptanui collected the data, and data interpretation was performed by Mishuk and Hansen, along with Qian, Harris, and Kiptanui. The manuscript was written and revised primarily by Mishuk, along with Qian and Hansen.
Topics: Cost-Benefit Analysis; Drugs, Generic; Humans; Social Class; Therapeutic Equivalency
PubMed: 29485953
DOI: 10.18553/jmcp.2018.24.3.252 -
BioMed Research International 2021Rational medicine use is an appropriate prescribing, dispensing, and patient use of medicines for the diagnosis, prevention, and treatment of diseases. It is affected by...
INTRODUCTION
Rational medicine use is an appropriate prescribing, dispensing, and patient use of medicines for the diagnosis, prevention, and treatment of diseases. It is affected by several factors. Irrational use of medicine is a widespread problem at all levels of care. This review is aimed at assessing the medicine use pattern in health facilities of Ethiopia using the medicine use pattern developed by WHO/INRUD.
METHODS
Relevant literature was searched from Google Scholar, PubMed, Hinari, Web of Science, and Scopus using inclusion and exclusion criteria. A systematic review was used to summarize the medicine use pattern in health facilities of Ethiopia, and that WHO core drug use indicators were employed.
RESULT
From 188 searched studies, 30 literatures were reviewed. The average number of drugs per encounter was 2.11. The percentage of encounters with antibiotics and injection was 57.16% and 22.39%, respectively. The percentage of drugs prescribed by generic name and from an essential drug list was 91.56% and 90.19%, respectively. On average, patients spent 5.14 minutes for consultation and 106.52 seconds for dispensing. From prescribed drugs, 67.79% were dispensed, while only 32.25% were labeled adequately. The availability of key essential medicines was 64.87%. The index of rational drug use value was 7.26. Moreover, the index of rational drug prescribing, index of rational patient-care drug use, and index of rational facility-specific drug use were 3.74, 2.51, and 1.01, respectively.
CONCLUSION
Ethiopian health facilities were faced with antibiotic overprescribing, short consultation, and dispensing times, poor labeling of medicines, poor availability of key drugs, and nonadherence to the essential drug list. Routine, multidisciplinary awareness creation, and regulation should be implemented to promote rational medicine use at a national level.
Topics: Cross-Sectional Studies; Drug Prescriptions; Drugs, Essential; Ethiopia; Humans; Medicine; Prospective Studies; Retrospective Studies; World Health Organization
PubMed: 34980999
DOI: 10.1155/2021/7041926 -
Clinical Interventions in Aging 2017Research on crisis teams for older adults with dementia is limited. This scoping review aimed to 1) conduct a systematic literature review reporting on the effectiveness... (Review)
Review
BACKGROUND
Research on crisis teams for older adults with dementia is limited. This scoping review aimed to 1) conduct a systematic literature review reporting on the effectiveness of crisis interventions for older people with dementia and 2) conduct a scoping survey with dementia crisis teams mapping services across England to understand operational procedures and identify what is currently occurring in practice.
METHODS
For the systematic literature review, included studies were graded using the Critical Appraisal Skills Programme checklist. For the scoping survey, Trusts across England were contacted and relevant services were identified that work with people with dementia experiencing a mental health crisis.
RESULTS
The systematic literature review demonstrated limited evidence in support of crisis teams reducing the rate of hospital admissions, and despite the increase in number of studies, methodological limitations remain. For the scoping review, only half (51.8%) of the teams had a care pathway to manage crises and the primary need for referral was behavioral or psychological factors.
CONCLUSION
Evidence in the literature for the effectiveness of crisis teams for older adults with dementia remains limited. Being mainly cohort designs can make it difficult to evaluate the effectiveness of the intervention. In practice, it appears that the pathway for care managing crisis for people with dementia varies widely across services in England. There was a wide range of names given to the provision of teams managing crisis for people with dementia, which may reflect the differences in the setup and procedures of the service. To provide evidence on crisis intervention teams, a comprehensive protocol is required to deliver a standardized care pathway and measurable intervention as part of a large-scale evaluation of effectiveness.
Topics: Aged; Crisis Intervention; Dementia; England; Female; Hospitalization; Humans; Mental Health Services
PubMed: 29042760
DOI: 10.2147/CIA.S142341