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Journal of the National Cancer Institute Jan 2016Little is known about the total patient burden associated with clinical development and where burdens fall most heavily during a drug development program. Our goal was... (Review)
Review
BACKGROUND
Little is known about the total patient burden associated with clinical development and where burdens fall most heavily during a drug development program. Our goal was to quantify the total patient burden/benefit in developing a new drug.
METHODS
We measured risk using drug-related adverse events that were grade 3 or higher, benefit by objective response rate, and trial outcomes by whether studies met their primary endpoint with acceptable safety. The differences in risk (death rate) and benefit (overall response rate) between industry and nonindustry trials were analyzed with an inverse-variance weighted fixed effects meta-analysis implemented as a weighted regression analysis. All statistical tests were two-sided.
RESULTS
We identified 103 primary publications of sunitinib monotherapy, representing 9092 patients and 3991 patient-years of involvement over 10 years and 32 different malignancies. In total, 1052 patients receiving sunitinib monotherapy experienced objective tumor response (15.7% of intent-to-treat population, 95% confidence interval [CI] = 15.3% to 16.0%), 98 died from drug-related toxicities (1.08%, 95% CI = 1.02% to 1.14%), and at least 1245 experienced grade 3-4 drug-related toxicities (13.7%, 95% CI = 13.3% to 14.1%). Risk/benefit worsened as the development program matured, with several instances of replicated negative studies and almost no positive trials after the first responding malignancies were discovered.
CONCLUSIONS
Even for a successful drug, the risk/benefit balance of trials was similar to phase I cancer trials in general. Sunitinib monotherapy development showed worsening risk/benefit, and the testing of new indications responded slowly to evidence that sunitinib monotherapy would not extend to new malignancies. Research decision-making should draw on evidence from whole research programs rather than a narrow band of studies in the same indication.
Topics: Angiogenesis Inhibitors; Antineoplastic Agents; Clinical Trials as Topic; Drug Approval; Humans; Indoles; Neoplasms; Pyrroles; Risk Assessment; Sunitinib; United States; United States Food and Drug Administration
PubMed: 26547927
DOI: 10.1093/jnci/djv292 -
Saudi Journal of Biological Sciences May 2019Faculty vitality is the main ingredient to enhance professional education and competence. Enriching the faculty vitality in key domains of teaching, assessing, research,... (Review)
Review
The impact and effectiveness of faculty development program in fostering the faculty's knowledge, skills, and professional competence: A systematic review and meta-analysis.
BACKGROUND
Faculty vitality is the main ingredient to enhance professional education and competence. Enriching the faculty vitality in key domains of teaching, assessing, research, professionalism, and administration is perceived to improve educational environment significantly and enhances the academic performance of learners. Faculty development program (FDP) has been considered as a stand-alone educational pedagogy in fostering knowledge and professional skills of faculty. However, few studies have provided objective reports about the impact of such programs in a healthcare system.
METHODS
This research was conducted by selecting data sources of PubMed-Medline, Wiley online library, Cochrane library, Taylor & Francis Online, CINAHL, Springer link, Proquest, ISI Web of knowledge, ScienceDirect, EJS, EBSCO, Blackwell, Emerald and ABI Inform. This search followed a step-wise approach defined by the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). A total of 37 studies that explored the impact of FDPs on medical and allied health faculty's professional development were selected.
RESULTS
This meta-analysis reported a mean effect size of 0.73 that reflects a significant and positive impact of FDPs in enhancing faculty's knowledge and professional competence (z-statistics of 4.46 significant at p-value < 0.05) using the random effects model and forest plot.
CONCLUSION
This article reiterates the incorporation of FDPs in all healthcare institutions for improving the academic performance of faculty with resultant enrichment of learners' knowledge and skills.
PubMed: 31048993
DOI: 10.1016/j.sjbs.2017.10.024 -
Research and Reports in Tropical... 2019Lymphatic filariasis (LF) is targeted for elimination by the year 2020. The Global Programme for Elimination of LF (GPELF) aims to achieve elimination by interrupting... (Review)
Review
Lymphatic filariasis (LF) is targeted for elimination by the year 2020. The Global Programme for Elimination of LF (GPELF) aims to achieve elimination by interrupting transmission through annual mass drug administration (MDA) of albendazole with ivermectin or diethylcarbamazine. The program has successfully eliminated the disease in 11 of the 72 endemic countries, putting in enormous efforts on systematic planning and implementation of the strategy. Mapping areas endemic for LF is a pre-requisite for implementing MDA, monitoring and evaluation are the components of programme implementation. This review was undertaken to assess how the mapping and impact monitoring activities have evolved to become more robust over the years and steered the LF elimination programme towards its goal. The findings showed that the WHO recommended mapping strategy aided 17 countries to delimit, plan and implement MDA in only those areas endemic for LF thereby saving resources. Availability of serological tools for detecting infection in humans (antigen/antibody assays) and molecular xenomonitoring (MX) in vectors greatly facilitated programme monitoring and evaluation in endemic countries. Results of this review are discussed on how these existing mapping and monitoring procedures can be used for re-mapping of unsurveyed and uncertain areas to ensure there is no resurgence during post-MDA surveillance. Further the appropriateness of the tests (Microfilaria (Mf)/antigenemia (Ag)/antibody(Ab) surveys in humans or MX of vectors for infection) used currently for post-MDA surveillance and their role in the development of a monitoring and evaluation strategy for the recently WHO recommended triple drug regimen in MDA for accelerated LF elimination are discussed.
PubMed: 31239804
DOI: 10.2147/RRTM.S134186 -
Nutrition Reviews Oct 2023The Child and Adult Care Food Program (CACFP) is a federal nutrition program that supports young children's nutrition. Its potential impacts on child well-being have not... (Review)
Review
CONTEXT
The Child and Adult Care Food Program (CACFP) is a federal nutrition program that supports young children's nutrition. Its potential impacts on child well-being have not been summarized.
OBJECTIVE
The objective of this review was to summarize the evidence for the impact of CACFP on children's diet quality, weight status, food insecurity, and cognitive development.
DATA SOURCES
Databases searched included MEDLINE, CAB Abstracts, Web of Science Core Collection, ERIC, PsycInfo, Dissertations & Theses Global (Proquest), EconLit, NBER, and the USDA's Economic Research Service (ERS), from database inception to November 12, 2021. Studies were included if the sample drew from child care programs serving children between the ages of 2 years and 18 years and if a comparison group of nonparticipating programs was included.
DATA EXTRACTION
Two reviewers independently extracted data on study design, year(s) of data collection, region, sample size, participant demographics, outcomes, and risk of bias.
DATA ANALYSIS
Due to the heterogeneity of the studies, a narrative synthesis was used.
RESULTS
Nineteen articles were reviewed, most of which had been published since 2012. Seventeen used cross-sectional designs. Twelve evaluated foods and beverages served; 4 evaluated dietary intake; 4 evaluated the child care nutrition environment; 2 evaluated food insecurity, 1 evaluated weight status; none evaluated cognitive outcomes. Studies typically found either a small beneficial association with CACFP or no significant association.
CONCLUSION
Currently, evidence for an association between CACFP and children's health is inconclusive, though it is slightly suggestive of a benefit for some dietary quality outcomes. More research, with stronger study designs, is needed.
SYSTEMATIC REVIEW REGISTRATION
A protocol for this systematic review was registered with the PROSPERO systematic review protocol registry (PROSPERO 2021 CRD42021254423).
Topics: Adult; Child; Child, Preschool; Humans; Child Health; Cross-Sectional Studies; Eating; Fruit
PubMed: 36882043
DOI: 10.1093/nutrit/nuad016 -
The American Journal of Managed Care Aug 2022CMS' coverage with evidence development (CED) policy allows Medicare beneficiaries to access promising therapies and services while additional data are collected. CED...
OBJECTIVES
CMS' coverage with evidence development (CED) policy allows Medicare beneficiaries to access promising therapies and services while additional data are collected. CED program characteristics are mostly unreported, and qualities associated with retirement of CED data collection requirements are unknown. We aimed to review and systematically describe CED program history and components and report programmatic elements correlated with retirement of CED data collection requirements, while identifying areas for policy improvement.
STUDY DESIGN
Systematic review.
METHODS
We extracted CED information from the CMS website, ClinicalTrials.gov, PubMed, internet searches, and communication with CMS.
RESULTS
There were 27 CED determinations from 2005 to 2022 in 8 therapeutic areas, with the most for cardiovascular diseases (8/27; 30%). Duration of CED programs (range, 1-16 years) and the number of related registries and clinical trials (range, 0-34) were widely variable. Only 4 CEDs have had data collection requirements with continued National Coverage Determination (NCD); 3 relate to cardiovascular therapies, and all have some public availability of findings resulting from CED-related data collection mechanisms. There were 2 instances of NCD revocation and deferral to local coverage decisions.
CONCLUSIONS
Changes in the CED program through improving program predictability and transparency with regard to outstanding questions, roles of relevant stakeholders, and requirements for reporting and reevaluation would strengthen the program's effectiveness. Ultimately, these improvements would provide incentives for stakeholder participation in data collection to achieve the goal of increasing access to beneficial therapies and improving clinical outcomes.
Topics: Aged; Humans; Medicare; Noncommunicable Diseases; Program Development; Registries; United States
PubMed: 35981123
DOI: 10.37765/ajmc.2022.88870 -
The Lancet Regional Health. Western... Jun 2023Previous systematic reviews naïvely combined biased effects of screening radiography or endoscopy observed in studies with various designs. We aimed to synthesize...
BACKGROUND
Previous systematic reviews naïvely combined biased effects of screening radiography or endoscopy observed in studies with various designs. We aimed to synthesize currently available comparative data on gastric cancer mortality in healthy, asymptomatic adults by explicitly classifying the screening effects through study designs and types of intervention effects.
METHODS
We searched multiple databases through October 31, 2022 for this systematic review and meta-analysis. Studies of any design that compared gastric cancer mortality among radiographic or endoscopic screening and no screening in a community-dwelling adult population were included. The method included a duplicate assessment of eligibility, double extraction of summary data, and validity assessment using the Risk Of Bias In Non-randomized Studies of Interventions tool. Bayesian three-level hierarchical random-effects meta-analysis synthesized data corrected for self-selection bias on the relative risk (RR) for per-protocol (PP) and intention-to-screen (ITS) effects. The study registration number at PROSPERO is CRD42021277126.
FINDINGS
We included seven studies in which a screening program was newly introduced (median attendance rate, 31%; at moderate-to-critical risk of bias), and seven cohort and eight case-control studies with ongoing screening programs (median attendance rate, 21%; all at critical risk of bias); thus, data of 1,667,117 subjects were included. For the PP effect, the average risk reduction was significant for endoscopy (RR 0.52; 95% credible interval: 0.39-0.79) but nonsignificant for radiography (0.80; 0.60-1.06). The ITS effect was not significant for both radiography (0.98; 0.86-1.09) and endoscopy (0.94; 0.71-1.28). The magnitude of the effects depended on the assumptions for the self-selection bias correction. Restricting the scope to East Asian studies only did not change the results.
INTERPRETATION
In limited-quality observational evidence from high-prevalence regions, screening reduced gastric cancer mortality; however, the effects diminished at a program level.
FUNDING
National Cancer Center Japan; and Japan Agency for Medical Research and Development.
PubMed: 37424675
DOI: 10.1016/j.lanwpc.2023.100741 -
Pediatrics and Neonatology Sep 2022Sensory stimulation is an intervention that, through peripheral stimuli, can facilitate brain organization, due to neuronal plasticity and cortical reorganization. The... (Review)
Review
BACKGROUND
Sensory stimulation is an intervention that, through peripheral stimuli, can facilitate brain organization, due to neuronal plasticity and cortical reorganization. The objective of this study was to evaluate the evidence about the effects of a multisensory stimulation program, applied on preterm infants, compared to any intervention or standard care, to improve feeding behaviour, and psychomotor development.
METHODS
The data sources included Medline (pubmed, EBSCO), Scopus and Web Of Science. The studies were randomized clinical trials published between 2015 and 2021 that analyzed multisensory stimulation interventions in preterm infants born less than 37 weeks of pregnancy.
RESULTS
Nine articles were identified, involving 545 preterm infants between 25 and 37 weeks of pregnancy. The studies applied different combinations of sensory stimulation. These interventions were related to a better time to achieve full oral feeding and higher consumption of human milk at discharge, better psychomotor development and visual function. All studies scored 6 or higher on the PEDro scale meaning good quality.
CONCLUSION
Multisensory stimulation in preterm infants may improve feeding, psychomotor development, and visual function.
Topics: Feeding Behavior; Humans; Infant, Newborn; Infant, Premature; Milk, Human
PubMed: 35934665
DOI: 10.1016/j.pedneo.2022.07.001 -
Cureus Nov 2021Interval programs have been developed for multiple sports, allowing athletes to return to sport-specific activity in a graded fashion, minimizing the risk of reinjury.... (Review)
Review
Interval programs have been developed for multiple sports, allowing athletes to return to sport-specific activity in a graded fashion, minimizing the risk of reinjury. However, there currently exists a gap in the literature surrounding the use of interval programs for the rehabilitation of punting and place-kicking athletes. We aim to perform a systematic review of the literature examining the use of interval kicking programs to aid punting and place-kicking athletes following a lower-extremity injury. Following PRISMA guidelines, a review was performed using PubMed and MEDLINE databases to evaluate the literature surrounding interval kicking programs for punting and place-kicking athletes. Search terms were combined using Boolean operators of "AND" and "OR". Articles included in this review met these criteria: 1) included patients with lower-extremity pain/injury, 2) reported a return to sport progressive program, and 3) analyzed the measure's ability to predict a successful return to sport. The initial search returned 115 articles. Seventy-nine of these articles were excluded after initial screening, leaving 36 full-text articles for final review. Of these final articles, there were no studies outlining the use of interval kicking programs by punting or place-kicking athletes. Of the articles reviewed, the most relevant was an interval kicking program developed by Arundale et al. specifically for the soccer athlete. Punting and place-kicking use biomechanically distinct patterns of movement, warranting a specific interval program. This review identified a gap in knowledge surrounding the use of interval programs in the rehabilitation of punting and place-kicking athletes. This review will now describe what is currently known regarding biomechanics of punting and place kicking, the injuries experienced by these athletes, and the benefit an individualized interval program could provide. There currently exists a gap in the literature surrounding the use of interval programs for the rehabilitation of punting and place-kicking athletes. The biomechanics and application of these skills are distinct, and an interval program designed specifically for these athletes is warranted. Future research should be dedicated to the development, implementation, and analysis of an interval kicking program designed for these athletes.
PubMed: 34934588
DOI: 10.7759/cureus.19725 -
Cell Proliferation Oct 2023The liver is a common secondary metastasis site of many malignant tumours, such as the colorectum, pancreas, stomach, breast, prostate, and lung cancer. The clinical... (Review)
Review
The liver is a common secondary metastasis site of many malignant tumours, such as the colorectum, pancreas, stomach, breast, prostate, and lung cancer. The clinical management of liver metastases is challenging because of their strong heterogeneity, rapid progression, and poor prognosis. Now, exosomes, small membrane vesicles that are 40-160 nm in size, are released by tumour cells, namely, tumour-derived exosomes (TDEs), and are being increasingly studied because they can retain the original characteristics of tumour cells. Cell-cell communication via TDEs is pivotal for liver pre-metastatic niche (PMN) formation and liver metastasis; thus, TDEs can provide a theoretical basis to intensively study the potential mechanisms of liver metastasis and new insights into the diagnosis and treatment of liver metastasis. Here, we systematically review current research progress about the roles and possible regulatory mechanisms of TDE cargos in liver metastasis, focusing on the functions of TDEs in liver PMN formation. In addition, we discuss the clinical utility of TDEs in liver metastasis, including TDEs as potential biomarkers, and therapeutic approaches for future research reference in this field.
Topics: Humans; Exosomes; Liver Neoplasms; Cell Communication; Pancreas; Biomarkers, Tumor; Tumor Microenvironment; Neoplasm Metastasis
PubMed: 36941028
DOI: 10.1111/cpr.13452 -
Nurse Education in Practice Nov 2023The aim of this scoping review is to summarize and critically evaluate research focused on nursing bridging education programs internationally. Specifically, this review... (Review)
Review
AIM
The aim of this scoping review is to summarize and critically evaluate research focused on nursing bridging education programs internationally. Specifically, this review addresses bridging from a: (1) Personal Support Worker (or similar) to a Registered Practical Nurse (or similar); and (2) Registered Practical Nurse (or similar) to a Registered Nurse.
BACKGROUND
Nursing bridging education programs support learners to move from one level of educational preparation or practice to another. These programs can therefore increase nursing workforce capacity. Global healthcare systems have faced nursing shortages for decades. Moreover, the presently insufficient nursing workforce is confronting an ever-increasing volume of needed healthcare that is rising with the global ageing demographic shift.
DESIGN
The Joanna Briggs Institute methods for scoping reviews, combined with Arksey and O'Malley's (2005) guidelines, were used with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews (PRISMA-ScR).
METHODS
MEDLINE (Ovid), CINAHL, EMBASE and SCOPUS databases were searched. Articles published in English that included Personal Support Workers, Registered Practical Nurses, Registered Nurses and/or nurses in similar categories who were studied through the process of a nursing bridging education program were included in the review. The study search was limited to papers published after 2005 (i.e., the beginning of nurse workload "overload" according to the Canadian Nurses Association). Braun and Clarke's (2006) thematic analysis was used in a content analysis of the included studies.
RESULTS
A total of 15 articles published between 2005 and 2022 were included. Four themes were generated: (1) participating in bridging education programs fuels both professional and personal development; (2) nursing bridging education programs enhance diversity in the nursing workforce; (3) student nurses do not anticipate the challenges associated with participating in a bridging program; and (4) mentor-mentee connection promotes academic learning and successful completion of nursing bridging education programs.
CONCLUSIONS
Despite experiencing challenges, participation in/completion of nursing bridging education programs leads to successful role transitioning and self-reported fulfillment of personal and professional aspirations. This review revealed the need for bridging programs to accommodate the unique needs of student nurses. Incorporation of support services, mentorship and faculty familiarity with varying nursing educational backgrounds facilitates role transitions by reducing the perceived challenges of bridging and promoting connection to foster learning. Nursing bridging education programs allow greater numbers of nurses to be trained to build workforce capacity and enable care for the world's rapidly ageing population.
Topics: Humans; Canada; Education, Nursing; Learning; Nursing Staff; Delivery of Health Care
PubMed: 37952474
DOI: 10.1016/j.nepr.2023.103833