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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 -
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 -
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 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 -
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 -
Artificial Intelligence in Medicine Oct 2022Early detection and prediction of suicidal behaviour are key factors in suicide control. In conjunction with recent advances in the field of artificial intelligence,... (Review)
Review
BACKGROUND
Early detection and prediction of suicidal behaviour are key factors in suicide control. In conjunction with recent advances in the field of artificial intelligence, there is increasing research into how machine learning can assist in the detection, prediction and treatment of suicidal behaviour. Therefore, this study aims to provide a comprehensive review of the literature exploring machine learning techniques in the study of suicidal behaviour prediction.
METHODS
A search of four databases was conducted: Web of Science, PubMed, Dimensions, and Scopus for research papers dated between January 2016 and September 2021. The search keywords are 'data mining', 'machine learning' in combination with 'suicidal behaviour', 'suicide', 'suicide attempt', 'suicidal ideation', 'suicide plan' and 'self-harm'. The studies that used machine learning techniques were synthesized according to the countries of the articles, sample description, sample size, classification tasks, number of features used to develop the models, types of machine learning techniques, and evaluation of performance metrics.
RESULTS
Thirty-five empirical articles met the criteria to be included in the current review. We provide a general overview of machine learning techniques, examine the feature categories, describe methodological challenges, and suggest areas for improvement and research directions. Ensemble prediction models have been shown to be more accurate and useful than single prediction models.
CONCLUSIONS
Machine learning has great potential for improving estimates of future suicidal behaviour and monitoring changes in risk over time. Further research can address important challenges and potential opportunities that may contribute to significant advances in suicide prediction.
Topics: Artificial Intelligence; Data Mining; Humans; Machine Learning; Suicidal Ideation
PubMed: 36207078
DOI: 10.1016/j.artmed.2022.102395 -
Journal of General Internal Medicine Oct 2015Health literacy (HL) and numeracy are measured by one of two methods: performance on objective tests or self-report of one's skills. Whether results from these methods... (Comparative Study)
Comparative Study Review
BACKGROUND
Health literacy (HL) and numeracy are measured by one of two methods: performance on objective tests or self-report of one's skills. Whether results from these methods differ in their relationship to health outcomes or use of health services is unknown.
METHODS
We performed a systematic review to identify and evaluate articles that measured both performance-based and self-reported HL or numeracy and examined their relationship to health outcomes or health service use. To identify studies, we started with an AHRQ-funded systematic review of HL and health outcomes. We then looked for newer studies by searching MEDLINE from 1 February 2010 to 9 December 2014. We included English language studies meeting pre-specified criteria. Two reviewers independently assessed abstracts and studies for inclusion and graded study quality. One reviewer abstracted information from included studies while a second checked content for accuracy.
RESULTS
We identified four "fair" quality studies that met inclusion criteria for our review. Two studies measuring HL found no differences between performance-based and self-reported HL for association with self-reported outcomes (including diabetes, stroke, hypertension) or a physician-completed rheumatoid arthritis disease activity score. However, HL measures were differentially related to a patient-completed health assessment questionnaire and to a patient's ability to interpret their prescription medication name and dose from a medication bottle. Only one study measured numeracy and found no difference between performance-based and self-reported measures of numeracy and colorectal cancer (CRC) screening utilization. However, in a moderator analysis from the same study, performance-based and self-reported numeracy were differentially related to CRC screening utilization when stratified by certain patient-provider communication behaviors (e.g., the chance to always ask questions and get the support that is needed).
DISCUSSION
Most studies found no difference in the relationship between results of performance-based and self-reported measures and outcomes. However, we identified few studies using multiple instruments and/or objective outcomes.
Topics: Cross-Sectional Studies; Health Knowledge, Attitudes, Practice; Health Literacy; Humans; Self Report
PubMed: 25917656
DOI: 10.1007/s11606-015-3288-4 -
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 -
Computer Methods and Programs in... Jul 2018Health Information Exchange (HIE) is known as a technology that electronically shares all clinical and administrative data throughout healthcare settings. Despite this... (Review)
Review
BACKGROUND AND OBJECTIVE
Health Information Exchange (HIE) is known as a technology that electronically shares all clinical and administrative data throughout healthcare settings. Despite this technology has a great potential in the healthcare industry, there is a limited and sparse evidence of articles which illustrated the impact of HIE on quality of care and cost-effectiveness. This work presents a systematic review that evaluates the impact of HIE on quality and cost-effectiveness, and the rates of HIE adoption and participation in healthcare organizations.
METHODS
We systematically searched all English papers that were indexed in four major databases (Science Direct, PubMed, IEEE and Web of Science) between 2005 and 2016. Consequently, 32 identified papers appeared in 21 international journals and conferences. Eligible studies independently were critically appraised, collected within data extraction form and then thematically analyzed by two reviewers and if necessary, the third author. The selected papers have been classified based on 11 main categories including publication year, journal and conference names, country and study design, types of data exchanged, healthcare levels, disease or disorder, participants in organizations and individuals, settings characteristics and HIE types, the impact of HIE on quality and cost-effectiveness, and the rates of HIE adoption and participation.
RESULTS
Of the 32 articles, 25 studies investigated the financial and clinical impact of HIE. Overwhelmingly, HIE studies have reported positive findings for quality and cost-effectiveness of care. 15 of HIE studies (60%) demonstrated positive financial effects and 16 studies (64%) reported positive effects on quality improvement of patient care. However, the overall quality of the evidences was low. In this regard, cohort study (59.38%) was the most common used study design. Nine studies presented the rates of HIE adoption and participation. The lowest and highest participation rates were 15.7% and 79%, respectively.
CONCLUSIONS
HIE can be considered as a superior potential for healthcare information system, resulting to promote patient care quality and reduce costs related to resource utilization. However, further researches are needed in order to provide a better understanding of this domain and accordingly attain new opportunities to increase users' participation and motivation for successfully adopting this technology.
Topics: Ambulatory Care; Cost-Benefit Analysis; Emergency Service, Hospital; Health Care Costs; Health Information Exchange; Humans; Quality of Health Care; Research Design
PubMed: 29852963
DOI: 10.1016/j.cmpb.2018.04.023 -
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