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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 -
Worldviews on Evidence-based Nursing Dec 2016Pressure ulcers are associated with substantial health burden, but could be preventable. Hospital-acquired pressure ulcers (HAPUs) prevention has become a priority for... (Review)
Review
BACKGROUND
Pressure ulcers are associated with substantial health burden, but could be preventable. Hospital-acquired pressure ulcers (HAPUs) prevention has become a priority for all healthcare settings, as it is considered a sign of quality of care providing. Intensive care unit (ICU) patients are at higher risk for HAPUs development. Despite the availability of published prevention strategies, there is a little evidence about which strategies can be safely integrated into routine standard care and have an impact on HAPUs prevention.
AIMS
The aim was to synthesize the best available evidence regarding the effectiveness of single strategies designed to reduce the incidence and prevalence of HAPUs development in ICUs.
METHODS
The search strategy was designed to retrieve studies published in English across CINAHL, Medline, Cochrane Central Register of Controlled Trials, Embase, Scopus, and Mednar between 2000 and 2015. All adult ICU participants were aged 18 years or over. This review included randomized controlled trials, quasi-experimental and comparative studies. The studies that were selected for retrieval were assessed by two independent reviewers for methodological validity prior to inclusion in the review using standardized critical-appraisal instruments.
RESULTS
The review included 25 studies, and the meta-analysis revealed a statistically significant effect of a silicon foam dressing strategy in reducing HAPUs incidence (effect size = 4.62; 95% CI: 0.05-0.29; p < .00001, effect size = 4.50; 95% CI: 0.05-0.31; p = .00001, respectively) in critically ill patients. Evidence of the effectiveness of nutrition, skin-care regimen, positioning and repositioning schedule, support surfaces, and the role of education in prevention of HAPUs development in the ICU was limited, which precludes strong conclusions.
LINKING EVIDENCE TO ACTION
The review provides an evidence-based guide to future priorities for clinical practice. In particular, a silicone foam dressing has positive impact in reducing sacrum and heel HAPUs incidence in the ICU.
Topics: Adult; Humans; Intensive Care Units; Pressure Ulcer; Program Evaluation
PubMed: 27712030
DOI: 10.1111/wvn.12177 -
International Journal of Nursing Studies Aug 2021The World Health Organization has emphasized the critical role of prenatal care in achieving the Millennium Development Goals to reduce child and maternal mortality. The... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
The World Health Organization has emphasized the critical role of prenatal care in achieving the Millennium Development Goals to reduce child and maternal mortality. The CenteringPregnancy program is a widely recognized model of prenatal care. Several countries have attempted to implement the program in prenatal care practice; however, its effectiveness on maternal and birth outcomes has not been systematically evaluated and analyzed.
OBJECTIVES
To determine the effect of the CenteringPregnancy program on improving maternal and birth outcomes, including low birth weight, preterm birth, and postpartum depression.
DESIGN
This study evaluated and analyzed randomized controlled trials by comparing the CenteringPregnancy program with o0bstetric led prenatal care. Maternal and birth outcomes of interest included low birthweight, preterm birth, and postpartum depressive symptoms.
DATA SOURCES
Embase, PubMed, CINAHL, Web of Science, and The Cochrane Library were utilized in this systematic review. Additionally, a supplemental Google Scholar search was performed to capture all relevant articles.
METHODS
All data were extracted independently by two trained researchers, who evaluated the quality of the study by examining the risk of bias. The biases of selection, allocation, measurement, reporting, and loss of follow-up were assessed using the Cochrane risk of bias for these included randomized controlled trials. A meta-analysis of eligible randomized controlled trials was conducted using Review Manager. Heterogeneity of studies was assessed using the I statistic.
RESULTS
Out of 591 articles reviewed, seven randomized controlled trials were included in this study. Findings showed that the CenteringPregnancy program was not associated with lower rates of preterm birth (0.88 [0.71-1.07], p = 0.20, I = 0%), low birth weight (0.87 [0.68-1.12], p =0.29, I = 0%), or 12-month postpartum depressive symptoms (0.07 [-0.12-0.26], p =0.46, I = 69%). However, the CenteringPregnancy program was associated with reduced rates of 6-month postpartum depressive symptoms (0.49 [0.40-0.59], p < 0.01, I = 40%).
CONCLUSIONS
Existing evidence suggests that the CenteringPregnancy program and obstetric led care have similar effects on reducing the rates of preterm birth and low birth weight but different effects on postpartum depressive symptoms. More studies are needed to examine the effect of the CenteringPregnancy program on the improvement of postpartum depressive symptoms. PROSPERO Registration number: CRD42020171831. Tweetable abstract: We conducted a systematic review and meta-analysis of randomized controlled trials to determine the effects of the CenteringPregnancy program on improving maternal and birth outcomes, including low birth weight, preterm birth, and postpartum depressive symptoms. Seven randomized controlled trials were included in this study. The findings suggested that the CenteringPregnancy program and obstetric led care had similar effects in reducing the rates of preterm birth and low birth weight. More studies are needed to examine the effect of the CenteringPregnancy program on the improvement of postpartum depressive symptoms.
Topics: Child; Female; Humans; Infant, Newborn; Parturition; Postpartum Period; Pregnancy; Premature Birth; Prenatal Care; Randomized Controlled Trials as Topic
PubMed: 34098451
DOI: 10.1016/j.ijnurstu.2021.103981 -
International Journal of Nursing Studies Jun 2020Falls often cause unexpected injuries that older adults find difficult to recover from (e.g., hip and other major fractures, intracranial bleeding); therefore, fall... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Falls often cause unexpected injuries that older adults find difficult to recover from (e.g., hip and other major fractures, intracranial bleeding); therefore, fall prevention and interventions are of particular significance.
OBJECTIVES
This study aimed to examine the effectiveness of multifactorial fall prevention interventions among community-dwelling older adults and compare subgroups that differed in terms of their degree of fall risk and the intensity and components of interventions.
METHODS
An exhaustive systematic literature search was undertaken using the following databases: Ovid-Medline, Ovid-Embase, and the Cochrane Central Register of Controlled Trials (Central). Two investigators independently extracted data and assessed the quality of the studies by examining the risk of bias. We conducted a meta-analysis of randomized controlled trials that had been published up to March 31st, 2019, using Review Manager.
RESULTS
Of 1,328 studies, 45 articles were relevant to this study. In total, 29 studies included participants in the high-risk group, 3 in the frail group, and 13 in the healthy older adult group. Additionally, 28 and 17 studies used active and referral multifactorial interventions, respectively. Multifactorial interventions included the following components: exercise, education, environmental modification, medication, mobility aids, and vision and psychological management. Multifactorial interventions significantly reduced fall rates in the high-risk (risk ratio 0.66; 95% confidence interval 0.52-0.84) and healthy groups (risk ratio 0.72; 95% confidence interval 0.58-0.89), when compared to the control group. Active multifactorial interventions (risk ratio 0.64; 95% confidence interval 0.51-0.80) and those featuring exercise (risk ratio 0.66; 95% confidence interval 0.54-0.80) and environmental modification also showed significantly reduced fall rates (risk ratio 0.65; 95% confidence interval 0.54-0.79) compared to usual care. Multifactorial interventions had a significantly lower number of people who experienced falls during the study period compared to usual care in the healthy group (risk ratio 0.77; 95% confidence interval 0.62-0.95). Active multifactorial interventions (risk ratio 0.73; 95% confidence interval 0.60-0.89) and those featuring exercise (risk ratio 0.79; 95% confidence interval 0.66-0.95) and environmental modification (risk ratio 0.80; 95% confidence interval 0.68-0.95) had a significantly lower number of people who experienced falls compared to those receiving usual care.
CONCLUSIONS
Active multifactorial interventions had positive effects on fall rates and the number of people experiencing falls. Thus, healthcare workers, including nurses, should be involved in planning fall prevention programs so that older adults can be provided with optimal care; multifactorial interventions that include exercise and environmental modification are particularly effective in reducing falls.
Topics: Accidental Falls; Aged; Aged, 80 and over; Exercise; Humans; Independent Living; Program Development; Vitamin D Deficiency
PubMed: 32272282
DOI: 10.1016/j.ijnurstu.2020.103564 -
CJEM Nov 2019The aim of this study is to identify the types of community paramedicine programs and the training for each.
OBJECTIVES
The aim of this study is to identify the types of community paramedicine programs and the training for each.
METHODS
A systematic review of MEDLINE, Embase, grey literature, and bibliographies followed a search strategy using common community paramedicine terms. All studies published in English up to January 22, 2018, were captured. Screening and extraction were completed in duplicate by two independent reviewers. The Mixed Methods Appraisal Tool (MMAT) was used to assess studies' methodological quality (full methodology on PROSPERO: CRD42017051774).
RESULTS
From 3,004 papers, there were 64 papers identified (58 unique community paramedicine programs). Of the papers with an appraisable study design (40.6%), the median MMAT score was 3 of 4 criteria met, suggesting moderate quality. Programs most often served frequent 911 callers (48.3%) and individuals at risk for emergency department admission, readmission, or hospitalization (41.4%); and 70.7% of programs were preventive home visits. Common services provided were home assessment (29.5%), medication management (39.7%), and referral and/or transport to community services (37.9%); and 77.6% of programs involved interprofessional collaboration. Community paramedicine training was described by 57% of programs and expanded upon traditional paramedicine training and emphasized technical skills. Study heterogeneity prevented meta-analysis.
CONCLUSION
Community paramedicine programs and training were diverse and allowed community paramedics to address a spectrum of population health and social needs. Training was poorly described. Enabling more programs to assess and report on program and training outcomes would support community paramedicine growth and the development of formalized training or education frameworks.
Topics: Canada; Community Health Services; Emergency Medical Services; Emergency Medical Technicians; Female; Humans; Interprofessional Relations; Male; Program Development; Program Evaluation
PubMed: 30885280
DOI: 10.1017/cem.2019.14 -
The International Journal of Health... Jul 2017Basic Medical Insurance (BMI) has changed remarkably over time in China because of health reforms that aim to achieve universal coverage and better health care with... (Review)
Review
Basic Medical Insurance (BMI) has changed remarkably over time in China because of health reforms that aim to achieve universal coverage and better health care with adequate efforts by increasing subsidies, reimbursement, and benefits. In this paper, we present the development of BMI, including financing and operation, with a systematic review. Meanwhile, Pudong New Area in Shanghai was chosen as a typical BMI sample for its coverage and management; a stratified cluster sampling survey together with an ordinary logistic regression model was used for the analysis. Enrolee satisfaction and the factors associated with enrolee satisfaction with BMI were analysed. We found that the reenrolling rate superficially improved the BMI coverage and nearly achieved universal coverage. However, BMI funds still faced dual contradictions of fund deficit and insured under compensation, and a long-term strategy is needed to realize the integration of BMI schemes with more homogeneous coverage and benefits. Moreover, Urban Resident Basic Medical Insurance participants reported a higher rate of dissatisfaction than other participants. The key predictors of the enrolees' satisfaction were awareness of the premium and compensation, affordability of out-of-pocket costs, and the proportion of reimbursement. These results highlight the importance that the Chinese government takes measures, such as strengthening BMI fund management, exploring mixed payment methods, and regulating sequential medical orders, to develop an integrated medical insurance system of universal coverage and vertical equity while simultaneously improving enrolee satisfaction.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Consumer Behavior; Female; Humans; Insurance, Health; Male; Middle Aged; Program Development; Sampling Studies; Surveys and Questionnaires; Young Adult
PubMed: 28664591
DOI: 10.1002/hpm.2430 -
New Directions For Child and Adolescent... Mar 2018Limited evidence describes promoting development and reducing violence in low- and middle-income countries (LMICs), a missed opportunity to protect children and promote... (Review)
Review
Limited evidence describes promoting development and reducing violence in low- and middle-income countries (LMICs), a missed opportunity to protect children and promote development and human capital. This study presents a systematic literature review of integrated early childhood development plus violence prevention (ECD+VP) interventions in LMICs. The search yielded 5,244 unique records, of which N = 6 studies met inclusion criteria. Interventions were in Chile, Jamaica, Lebanon, Mexico, Mozambique, and Turkey. Five interventions were parent education programs, including center-based sessions (n = 3) and home visiting (n = 2), while one intervention was a teacher education program. All but one study reported improvements in both child development and maltreatment outcomes. The dearth of evidence on ECD+VP interventions suggests additional research is needed. Integrated ECD+VP interventions may improve multiple child outcome domains while leveraging limited resources in LMICs.
Topics: Child Development; Child, Preschool; Developing Countries; Humans; Program Development; Violence
PubMed: 29537183
DOI: 10.1002/cad.20230 -
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