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European Journal of Physical and... Jun 2021There has been an increase in the use of questionnaires as tools for the subjective evaluation of patients with neuro-musculoskeletal problems. The aim of this study was...
INTRODUCTION
There has been an increase in the use of questionnaires as tools for the subjective evaluation of patients with neuro-musculoskeletal problems. The aim of this study was to analyze the psychometric properties of the questionnaires published in Italian for the evaluation of cervical and lumbar spine pain and related dysfunction.
EVIDENCE ACQUISITION
Two blinded bibliographical searches were carried out on seven databases, regarding back, lumbar and/or cervical musculoskeletal problems. Both the structural characteristics and the psychometric aspects of each of the questionnaires were extracted from each of the selected articles. The structural characteristics were: full name, acronym, author and date of adaptation to the Italian language, what it measures, number of items, time to complete, the result scale, where the points are located and the cost. The psychometric aspects were: standard error of measurement (SEM), minimum detectable change (MDC), minimal clinically important difference (MCID), test-retest reliability, internal consistency, criterion validity, construct validity and sensitivity to changes.
EVIDENCE SYNTHESIS
For the structural characteristics of the questionnaires identified for the valuation of the lumbar area, the number of items ranged between 10 and 24. Only two of the questionnaires presented specific categories, and the time to complete ranged between 5 and 7 minutes. The reliability of the questionnaires ranged between 0.869 and 0.961. None of the questionnaires calculated the inter-observer reliability. The internal consistency ranged between 0.82 and 0.90 for criterion validity. None of the questionnaires calculated sensitivity, SEM, MDC or MCID, with the exception of the Fear-Avoidance Beliefs Questionnaire, which showed a value of 12 on MDC. For the assessment of the cervical region, the number of items ranged from 6 to 20. Three of the questionnaires had sub-categories, and the time to complete them ranged between 2 and 5 minutes. The test-retest reliability ranged between 0.78 and 0.997. The internal consistency ranged between 0.842 and 0.942.
CONCLUSIONS
The Italian versions of the questionnaires present good basic structural and psychometric characteristics for the evaluation of patients with back, lumbar and/or cervical musculoskeletal disorders. The analysis of the structural and psychometric characteristics of these questionnaires is fundamental to identify the best tools to use in research and in clinical practice.
Topics: Disability Evaluation; Humans; Italy; Low Back Pain; Musculoskeletal Pain; Neck Pain; Pain Measurement; Psychometrics; Surveys and Questionnaires; Translating
PubMed: 33258360
DOI: 10.23736/S1973-9087.20.06280-2 -
Journal of Dental Education Aug 2015The aim of this study was to review the effectiveness of methods used for teaching dental anatomy carving to dental students in operative dentistry as evaluated in... (Comparative Study)
Comparative Study Review
The aim of this study was to review the effectiveness of methods used for teaching dental anatomy carving to dental students in operative dentistry as evaluated in published studies. This systematic review is described in accordance with the PRISMA statement. Two independent reviewers performed a systematic literature search of research published from January 1945 until May 2014. Seven databases were screened: MedLine (PubMed), Lilacs, IBECS, Web of Science, Scopus, SciELO, and The Cochrane Library. After removing duplicates, only studies using dental carving to assess the practical knowledge of anatomy were selected. The tabulated data were organized by title of article, names of authors, number of students assessed, assessment method, material used, groups tested, main results, and conclusions. The methodology quality was assessed according to the Cochrane Handbook for Systematic Reviews of Interventions. Initially, 2,258 studies were identified in all databases. Five articles met the eligibility criteria and were included in this review. According to these studies, the geometric method, teaching step-by-step along with the teacher, and adjuvant methods such as the use of tutors and teaching through digital media with DVDs proved to be effective in improving learning. There is no standard technique that is widely accepted for the teaching of dental carving, nor is there an appropriately validated method of evaluation to verify whether the teaching methods used are effective for the acquisition of skills and expertise in dental anatomy by students.
Topics: Anatomy; Dentistry, Operative; Education, Dental; Humans; Motor Skills; Sculpture; Teaching
PubMed: 26246529
DOI: No ID Found -
Archives of Physiotherapy 2018There is a need for psychosocial interventions to address the escalating mental health burden in Sub-Saharan Africa (SSA). Physiotherapists could have a central role in... (Review)
Review
BACKGROUND
There is a need for psychosocial interventions to address the escalating mental health burden in Sub-Saharan Africa (SSA). Physiotherapists could have a central role in reducing the burden and facilitating recovery within the multidisciplinary care of people with mental health problems. The aim of this systematic review was to explore the role of physiotherapists within the current mental health policies of SSA countries and to explore the current research evidence for physiotherapy to improve functional outcomes in people with mental health problems in SSA.
METHODS
The Mental Health Atlas and MiNDbank of the World Health Organization were screened for the role of physiotherapy in mental health plans. Next, we systematically searched PubMed from inception until August 1st, 2017 for relevant studies on physiotherapy interventions in people with mental health problems in SSA. The following search strategy was used: "physiotherapy" OR "physical therapy" OR "rehabilitation" AND "mental" OR "depression" OR "psychosis" OR "schizophrenia" OR "bipolar" AND the name of the country.
RESULTS
The current systematic review shows that in 22 screened plans only 2 made reference to the importance of considering physiotherapy within the multidisciplinary treatment. The current evidence (N studies = 3; n participants = 94) shows that aerobic exercise might reduce depression and improve psychological quality of life, self-esteem, body image and emotional stress in people with HIV having mental health problems. In people with depression moderate to high but not light intensity aerobic exercise results in significantly less depressive symptoms ( = 1, = 30). Finally, there is evidence for reduction in post-traumatic stress symptoms (avoidance and arousal), anxiety and depression following body awareness related exercises (N = 1, = 26).
CONCLUSIONS
Our review demonstrated that physiotherapy is still largely neglected in the mental health care systems of SSA. This is probably due to poor knowledge of the benefits of physiotherapy within mental health care by policymakers, training institutes, and other mental health care professionals in SSA. Based on the current scientific evidence, this paper recommends the adoption of physiotherapy within mental health care services and investment in research and in training of professionals in SSA.
PubMed: 29423279
DOI: 10.1186/s40945-018-0043-2 -
Health Policy (Amsterdam, Netherlands) Jul 2015Cost-of-illness studies, the systematic quantification of the economic burden of diseases on the individual and on society, help illustrate direct budgetary consequences... (Review)
Review
Cost-of-illness studies, the systematic quantification of the economic burden of diseases on the individual and on society, help illustrate direct budgetary consequences of diseases in the health system and indirect costs associated with patient or carer productivity losses. In the context of the BURQOL-RD project ("Social Economic Burden and Health-Related Quality of Life in patients with Rare Diseases in Europe") we studied the evidence on direct and indirect costs for 10 rare diseases (Cystic Fibrosis [CF], Duchenne Muscular Dystrophy [DMD], Fragile X Syndrome [FXS], Haemophilia, Juvenile Idiopathic Arthritis [JIA], Mucopolysaccharidosis [MPS], Scleroderma [SCL], Prader-Willi Syndrome [PWS], Histiocytosis [HIS] and Epidermolysis Bullosa [EB]). A systematic literature review of cost of illness studies was conducted using a keyword strategy in combination with the names of the 10 selected rare diseases. Available disease prevalence in Europe was found to range between 1 and 2 per 100,000 population (PWS, a sub-type of Histiocytosis, and EB) up to 42 per 100,000 population (Scleroderma). Overall, cost evidence on rare diseases appears to be very scarce (a total of 77 studies were identified across all diseases), with CF (n=29) and Haemophilia (n=22) being relatively well studied, compared to the other conditions, where very limited cost of illness information was available. In terms of data availability, total lifetime cost figures were found only across four diseases, and total annual costs (including indirect costs) across five diseases. Overall, data availability was found to correlate with the existence of a pharmaceutical treatment and indirect costs tended to account for a significant proportion of total costs. Although methodological variations prevent any detailed comparison between conditions and based on the evidence available, most of the rare diseases examined are associated with significant economic burden, both direct and indirect.
Topics: Cost of Illness; Europe; Health Care Costs; Humans; Orphan Drug Production; Prevalence; Quality of Life; Rare Diseases
PubMed: 25661982
DOI: 10.1016/j.healthpol.2014.12.016 -
Bone Reports Dec 2021Denosumab is a monoclonal antibody that has been approved to treat osteoporosis, skeletal metastasis, and giant cell tumor of bone in skeletally mature patients. Due to... (Review)
Review
Denosumab is a monoclonal antibody that has been approved to treat osteoporosis, skeletal metastasis, and giant cell tumor of bone in skeletally mature patients. Due to its potential adverse effects on normal bone growth, its use has not yet been approved in skeletally immature patients; however, the use of this agent in such patients with overt or dysregulated bone resorptive conditions has been explored in recent years. While most studies have proven the effectiveness of denosumab in controlling the progression of various disorders in skeletally immature patients, they have also revealed that refractory hypercalcemia often follows the discontinuation of denosumab treatment, raising a concern over the use of this agent in these patients. Thus, this study was designed to better understand the pathology of this condition through a systematic review of the published literature. Our analysis suggests that this condition has a potential male predisposition, that there is a correlation between the duration of denosumab treatment and patient age, and that this condition often occurs within 3 months after the last administration of denosumab in skeletally immature patients but is significantly less likely in adults. These results may further underscore that high bone formation and bone turnover rates are critically associated with hypercalcemia after the discontinuation of denosumab. In contrast, given that not all skeletally immature patients develop hypercalcemia, it is probable that other unidentified factors are involved in the pathology of this condition.
PubMed: 34825020
DOI: 10.1016/j.bonr.2021.101148 -
Journal of Ethnopharmacology Feb 2022Aralia, which belongs to Araliaceae family, is mainly distributed in Asia, such as China, Japan and South Korea. It has a long medicinal history and is widely used in...
ETHNOPHARMACOLOGICAL RELEVANCE
Aralia, which belongs to Araliaceae family, is mainly distributed in Asia, such as China, Japan and South Korea. It has a long medicinal history and is widely used in the treatment of various diseases, such as hepatitis, rheumatoid arthritis, bruises, lumps and carbuncles.
AIM OF THE STUDY
The purpose of this review is to systematically evaluate the traditional uses, phytochemistry, pharmacology, toxicity and quality control of main medicinal plants of Aralia, discusses the application of ethnic medicine, modern scientific research and the relationship between them, and put forward some suggestions to promote the further development and utilization of Aralia.
MATERIALS AND METHODS
The relevant information on Aralia was collected through electronic databases (PubMed, Web of Science, Science Direct, Springer, CNKI and Wanfang), Chinese herbal classics, Ph.D. and M.Sc. dissertations, Chinese Pharmacopoeia. Plant names were verified by "The Plant List" (http://www.theplantlist.org). The literature cited in this review can be traced back to 1878 to 2021.
RESULTS
More than 290 chemical constituents have been isolated from the genus Aralia, including triterpenoid saponins, terpenoids, organic acids, flavonoids, polyacetylenes, phenylpropanoids and other constituents. Pharmacological studies have shown that the extracts and compounds of Aralia have a wide range of pharmacological activities, including anti-inflammation, analgesic, anti-tumor, liver protection, protection of cardiovascular and nervous system, regulating substance metabolism, antibacterial, antiviral and antioxidation.
CONCLUSIONS
The genus Aralia is not only an excellent traditional herbal medicine, but also a source of bioactive molecules with good application prospects. However, the structure-activity relationship, in vivo activity and action mechanism of its bioactive components need to be further studied. In addition, more toxicological and quality control studies are essential to evaluate the efficacy and safety of Aralia as medicine.
Topics: Animals; Aralia; Ethnopharmacology; Humans; Medicine, East Asian Traditional; Phytochemicals; Plant Extracts; Quality Control
PubMed: 34627983
DOI: 10.1016/j.jep.2021.114671 -
Journal of Managed Care & Specialty... Dec 2017Biosimilars undergo an abbreviated licensure pathway called 351(k), which was created by the Biologics Price Competition and Innovation Act of 2009. This approval... (Review)
Review
BACKGROUND
Biosimilars undergo an abbreviated licensure pathway called 351(k), which was created by the Biologics Price Competition and Innovation Act of 2009. This approval process is different from the 351(a) pathway for original biologic approval and, as of August 2017, has been used to approve 5 biosimilars in the United States.
OBJECTIVE
To identify the types and quantities of evidence required by the FDA for biosimilar approval and the corresponding evidence manufacturers have provided in their 351(k) biosimilar approval applications.
METHODS
To collect data for this review, we searched through drug-specific FDA approval documents and approval-related FDA webcasts for approval indications and dates; reference product names; formulations; postmarketing requirements and commitments; evidence used for extrapolation claims; advisory committee votes; and evidence on similarity in analytical and functional characteristics, pharmacokinetics, pharmacodynamics, efficacy, safety, and immunogenicity.
RESULTS
All biosimilars approved in the United States provided a large evidence base to demonstrate similarity in analytical and functional characteristics-3 to 5 clinical studies showed similarity in pharmacokinetics and pharmacodynamics, and 1 to 2 clinical studies demonstrated efficacy. Safety and immunogenicity were evaluated across all clinical studies. All biosimilars were compared with either the U.S.-licensed reference product or the reference product licensed by the European Union. Extrapolation allowed biosimilars to be approved for indications in which clinical studies were not conducted. The few indications for which biosimilars did not share approval with the reference product were due to market exclusivity protection. None of the 5 biosimilars have been approved as interchangeable in the United States.
CONCLUSIONS
The approval process for the first 5 biosimilars on the market in the United States provides a baseline understanding of what type and degree of evidence is required for biosimilar approval.
DISCLOSURES
There was no external funding for this study. Hung reports employment as a pharmacist for CVS Health, an AHRQ F32 grant, and meeting/accommodation/travel support from AACP, DIA, and ISPOR, all outside the submitted work. Vu and Mostovoy have nothing to disclose. Study concept and design were contributed by Hung and Mostovoy, along with Vu. Hung and Vu collected the data, and data interpretation was performed primarily by Hung, along with Mostovoy. The manuscript was written by Hung and Vu and revised by all the authors. Some of the study results were previously presented as a poster at the ISPOR 22nd Annual International Meeting; May 20-24, 2017; in Boston, Massachusetts.
Topics: Biosimilar Pharmaceuticals; Clinical Trials as Topic; Drug Approval; Drug Industry; Humans; United States; United States Food and Drug Administration
PubMed: 29172975
DOI: 10.18553/jmcp.2017.23.12.1234 -
Journal of the Mechanical Behavior of... Sep 2023The purpose of this study was to systematically review the impact of nanofillers on the physicomechanical properties of resin-based pit and fissure sealants (RBS). This... (Review)
Review
The purpose of this study was to systematically review the impact of nanofillers on the physicomechanical properties of resin-based pit and fissure sealants (RBS). This review included in vitro studies with full-length English-language articles reporting on the physicomechanical properties of nanofilled RBS until February 2023. PubMed, Web of Sciences, Scopus, and LILACS databases were accessed for literature searches. The review was formulated based on the Preferred Reporting Items for Systematic Review and Meta-Analyses (PRISMA) guidelines and used the Consolidated Standards of Reporting Trials (CONSORT) guidelines and risk of bias Cochrane tool for quality assessment. The search resulted in 539 papers, of which 22 were eligible to be included in the review. Inorganic, polymeric, core-shell, and composite nanomaterials were used to reinforce the studied RBS. The inherent nature of the nanomaterial used, its morphology, concentration, and volume used were the primary parameters that determined the nanomaterial's success as a filler in RBS. These parameters also influenced their interaction with the resin matrix, which influenced the final physicomechanical properties of RBS. The use of nanofillers that were non-agglomerated and well dispersed in the resin matrix enhanced the physicomechanical properties of RBS.
Topics: Humans; Pit and Fissure Sealants; Nanostructures; Polymers; Reference Standards; Dental Caries
PubMed: 37499522
DOI: 10.1016/j.jmbbm.2023.106037 -
Journal of Alternative and... Aug 2018As positive evidence emerges for the use of an intervention to treat a health problem, the intervention gradually becomes incorporated into treatment guidelines (TGs) or... (Review)
Review
INTRODUCTION
As positive evidence emerges for the use of an intervention to treat a health problem, the intervention gradually becomes incorporated into treatment guidelines (TGs) or clinical practice guidelines (CPGs) that are related to that health problem. To assess whether this general hypothesis can apply to acupuncture, 96 health problems were identified for which positive conclusions in systematic reviews and meta-analyses regarding the effectiveness of acupuncture have been made and then searched for TGs or CPGs that have recommended the use of acupuncture.
METHODS
Through August 31, 2017, searches were performed in relevant medical databases and Google using "treatment guideline," "clinical practice guideline," and the names of the 96 medical conditions as search terms. A "snow-balling" search approach was adopted. All positive recommendations were added into the registry.
RESULTS
A total of 1311 publications were found that recommended using acupuncture published between 1991 and 2017. The number per year reached 50 in 2005 and 100 in 2009. In addition, 2189 positive recommendations were found for the use of acupuncture. Of these, 1486 were related to 107 pain indications and 703 were related to 97 nonpain indications. These recommendations were made by a wide range of groups, such as government health institutions, national guideline, and medical specialty groups. The recommendations came from around the world but were especially abundant in North America, Europe, and Australasia.
DISCUSSION AND CONCLUSION
Considerably more recommendations were found for the use of acupuncture than are known within the acupuncture or medical communities. A trend by year was also found; a rise in the number of positive statements about acupuncture was typically followed by a rise in the number of recommendations of acupuncture. Thus, the recommendations followed the emergent evidence for acupuncture. Better implementation plans need to be developed for the CPG/TG recommendations about acupuncture to be more effective/efficient.
Topics: Acupuncture Therapy; Bibliometrics; Humans; Practice Guidelines as Topic
PubMed: 29912569
DOI: 10.1089/acm.2018.0092 -
PloS One 2023Undernutrition (Body Mass Index < 18.5 kg/m2) is a common problem and a major cause of hospital admission for patients living with HIV. Though sub-Saharan Africa is the... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Undernutrition (Body Mass Index < 18.5 kg/m2) is a common problem and a major cause of hospital admission for patients living with HIV. Though sub-Saharan Africa is the most commonly affected region with HIV and malnutrition, a meta-analysis study that estimates the prevalence and correlates of undernutrition among adults living with HIV has not yet been conducted. The objective of this study was to determine the pooled prevalence of undernutrition and associated factors among adults living with HIV/AIDS in sub-Saharan Africa.
METHODS
Studies published in English were searched systematically from databases such as PubMed, Google Scholar, and gray literature, as well as manually from references in published articles. Observational studies published from 2009 to November 2021 were included. The data extraction checklist was prepared using Microsoft Excel and includes author names, study area, publication year, sample size, prevalence/odds ratio, and confidence intervals. The results were presented and summarized in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) standard. Heterogeneity was investigated using the Q test, I2, τ2, τ and predictive interval. STATA version 17 was used to analyze the data. A meta-analysis using a random-effects model was used to determine the overall prevalence and adjusted odds ratio. The study has been registered in PROSPERO with a protocol number of CRD42021268603.
RESULTS
In this study, a total of 44 studies and 22,316 participants were included. The pooled prevalence of undernutrition among adult people living with HIV (PLWHIV) was 23.72% (95% CI: 20.69-26.85). The factors associated with undernutrition were participants' age (AOR = 0.5, 95% CI: 0.29-0.88), gender (AOR = 2.08, 95% CI: 0.22-20.00), World Health Organization (WHO) clinical stage (AOR = 3.25, 95% CI: 2.57-3.93), Cluster of Differentiation 4 (CD4 count) (AOR = 1.94, 95% CI: 1.53-2.28), and duration of ART (AOR = 2.32, 95% CI: 1.6-3.02).
CONCLUSION
The pooled prevalence of undernutrition among adult PLWHIV in sub-Saharan Africa remained high. WHO clinical stage, CD4 count, duration of ART treatment, age, and sex were found to be the factors associated with undernutrition. Reinforcing nutrition counseling, care, and support for adults living with HIV is recommended. Priority nutritional screening and interventions should be provided for patients with advanced WHO clinical stages, low CD4 counts, the male gender, younger age groups, and ART beginners.
Topics: Humans; Adult; Male; Nutrition Assessment; Prevalence; Nutritional Status; HIV Infections; Malnutrition; Africa South of the Sahara
PubMed: 36961844
DOI: 10.1371/journal.pone.0283502