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1.
Implement Res Pract ; 5: 26334895231220259, 2024.
Article in English | MEDLINE | ID: mdl-38322801

ABSTRACT

Background: Police and mental health co-responder programs operate internationally and can be effective in providing timely and appropriate assessment, brief intervention, and referral services for people experiencing mental health crises. However, these models vary greatly, and little is known about how the design and implementation of these programs impacts their effectiveness. Method: This study was a qualitative, post hoc implementation determinant evaluation of mental health co-responder units in Brisbane, Australia, comprising of verbal or written interviews with police and mental health staff with an on-road role in the co-responder units, and their managers. The Consolidated Framework for Implementation Research was used to identify barriers and enablers to the program's implementation and effectiveness. Results: Participants (n = 30) from all groups felt strongly that the co-responder units are a substantial improvement over the usual police management of mental health crisis cases, and lead to better outcomes for consumers and the service. Enablers included an information-sharing agreement; the Mental Health Co-Responder (MHCORE) program's compatibility with existing police and mental health services; and the learning opportunity for both organizations. Barriers included cultural differences between the organizations, particularly risk-aversion to suicidality for police and a focus on least-restrictive practices for health; extensive documentation requirements for health; and a lack of specific mental health training for police. Conclusions: Using an evidence-based implementation science framework enabled identification of a broad range of contextual barriers and enablers to implementation of police mental health co-responder programs. Adapting the program to address these barriers and enablers during the planning, implementation, monitoring, and evaluation phases increases the likelihood of the service's effectiveness. These findings will inform the spread and scale of the co-responder program across Queensland, and will be relevant to police districts internationally considering implementing a co-responder program.


A large and rising proportion of calls to police relate to mental health crises, however police lack the resources, knowledge, training and supports to effectively address these crises. In Brisbane, Australia people in mental health crisis who are attended by police are routinely transported under an Emergency Examination Authority to a hospital emergency department. This is time-consuming for both the consumer and police, may be stressful or distressing for the consumer, and can put pressure on emergency departments. Co-responder programs team a senior mental health clinician with a senior police officer. There is evidence that a qualified and experienced mental health clinician providing people in mental health crisis with a timely assessment and brief intervention in the field, and where appropriate, referral to support services, leads to better outcomes for the consumer, reduced hospital transport, reduced time per case, and reduced overall service costs. Although many papers have been written evaluating the outcomes of these programs, few have considered factors that impact the implementation, effectiveness, and sustainment of co-responder teams. We used an implementation science approach based on the Consolidated Framework for Implementation Research to identify barriers to and enablers of mental health co-responder program implementation within an Australian metropolitan setting. Understanding these barriers and enablers allows a more streamlined, better-informed roll-out of future programs, and adaptation of existing models to improve effectiveness. The results will be relevant for any police district considering implementing a mental health co-responder program. They will also be used to inform the ongoing program.

2.
Eur J Prosthodont Restor Dent ; 31(2): 92-103, 2023 May 31.
Article in English | MEDLINE | ID: mdl-35917210

ABSTRACT

OBJECTIVES: To determine the success, survival, peri-implant health and prosthetic complications in head and neck cancer patients receiving oral rehabilitation utilising dental implants between 2008 and the present day. MATERIALS AND METHODS: Service evaluation. Survival Group: Retrospective review of records to determine implant survival and prosthetic complications. Success Group: Examination to determine implant success and health. RESULTS: Survival Group: 260 implants in 81 individuals, median follow up 49.2 months. 89.3% implant survival at 96 months, no further failures up to 133 months. 40.9% individuals required repair or remake of prosthesis by 72 months - mostly denture re-lines. Success group: 164 implants in 48 individuals, median follow up 56 months. Peri-implant mucositis detected in 22% of fixtures (37.5% individuals); peri-implantitis in 12.8% (25% individuals); 33.3% fixtures exhibiting periimplantitis at 120 months. Previous smoking significantly associated with development of peri-implantitis (HR 2.372, p=0.032, 95CI:1.232, 93.317). Compromised survival (e.g. peri-implantitis), absolute (not in mouth) or clinical failure estimated to occur in 28.1% fixtures at 101 months, mostly due to peri-implantitis. CONCLUSIONS: There is a large burden of ongoing care in this cohort, requiring interventions to improve peri-implant health and maintain complex prostheses. Oral rehabilitation and ongoing maintenance in this cohort is complex and multi-disciplinary.


Subject(s)
Dental Implants , Head and Neck Neoplasms , Peri-Implantitis , Humans , Peri-Implantitis/etiology , Retrospective Studies , Dental Implants/adverse effects , Head and Neck Neoplasms/surgery , Head and Neck Neoplasms/chemically induced , Head and Neck Neoplasms/complications
3.
Int Nurs Rev ; 67(4): 476-483, 2020 Dec.
Article in English | MEDLINE | ID: mdl-32767464

ABSTRACT

AIM: The purpose of this research was to determine the effectiveness of a mobile health or mHealth application to improve hypertension health literacy among vulnerable populations in India. Additionally, we sought to estimate relationships between participant knowledge on hypertension and sociodemographic variables. BACKGROUND: The World Health Organization advocates for the use of mobile technology to improve public health outcomes. INTRODUCTION: The incidence of hypertension is on the rise in India, and effective and sustainable interventions are needed. METHODS: A quantitative single arm pre-test post-test interventional and correlational design was used to test the hypertension mHealth application among participants in a limited resource setting. A paired t-test was performed to compare pre- and post-test results after participant use of the mHealth application. A regression model was used to estimate relationships between participant hypertension health literacy and sociodemographic variables. RESULTS: A statistically significant improvement in test scores among participants after use of the mHealth app was found. Sociodemographic characteristics such as living in an urban environment, married, increased number of people living in household and alcohol use were determined to have a statistically significant effect on improvement of test score. DISCUSSION: Results indicated the application was effective among participants with varied literacy and health literacy levels. These findings contribute to the potential widespread scalability of the app among populations with varied demographics. CONCLUSION: This application provides an effective and valuable culturally tailored educational resource for nurses and other health providers to use to improve hypertension health literacy among vulnerable populations in India. IMPLICATIONS FOR NURSING PRACTICE AND HEALTH POLICY: This study contributes to nursing and health policy by answering a call from the World Health Organization to implement and research mHealth interventions to improve health outcomes, particularly in a low and middle income country where preventive health access is limited.


Subject(s)
Health Literacy , Hypertension , Telemedicine , Humans , Hypertension/prevention & control , India
4.
Appl Opt ; 59(8): 2569-2579, 2020 Mar 10.
Article in English | MEDLINE | ID: mdl-32225798

ABSTRACT

A novel stacking procedure is presented for volume phase holographic gratings (VPHGs) recorded in photopolymer material using Corning Willow Glass as a flexible substrate in order to achieve broader angular and spectral selectivity in a diffractive device with high efficiency for solar and LED applications. For the first time to our knowledge, we have shown a device designed for use with a white LED that has the same input and output angles and high efficiency when illuminated by different wavelengths. In this paper, two VPHGs were designed, experimentally recorded, and tested when illuminated at normal incidence. The experimental approach is based on stacking two individual gratings in which the spatial frequency and slant have been tailored to the target wavelength and using real-time on-Bragg monitoring of the gratings in order to control the recorded refractive index modulation, thereby optimizing each grating efficiency for its design wavelength. Lamination of the two gratings together was enabled by using a flexible glass substrate (Corning Willow Glass). Recording conditions were studied in order to minimize the change in diffraction efficiency and peak diffraction angle during lamination and bleaching. The final fabricated stacked device was illuminated by a white light source, and its output was spectrally analyzed. Compared to a single grating, the stacked device demonstrated a twofold increase in angular and wavelength range. The angular and wavelength selectivity curves are in good agreement with the theoretical prediction for this design. This approach could be used to fabricate stacked lenses for white light LED or solar applications.

5.
Eur J Clin Pharmacol ; 76(4): 507-513, 2020 Apr.
Article in English | MEDLINE | ID: mdl-31938856

ABSTRACT

INTRODUCTION: Twenty-five years ago, the World Health Organization (WHO) published the Guide to Good Prescribing (GGP), followed by the accompanying Teacher's Guide to Good Prescribing (TGGP). The GGP is based on a normative 6-step model for therapeutic reasoning and prescribing, and provides a six-step guide for students to the process of rational prescribing. METHOD: We reviewed the need to update both WHO publications by evaluating their use and impact, including new (theoretical) insights and demands. Based on information from literature, Internet, and other (personal) sources, we draw the following conclusions. RESULTS: 1. An update of the GGP and TGGP, both in terms of content and form, is necessary because of the current need for these tools (irrational medicine use and unavailability of medicines), the lack of similar documents, and the lack of connection with recent developments, such as Internet and modern education; 2. The basic (6-step) model of the GGP is effective in terms of rational prescribing in the undergraduate situation and is still consistent with current theories about (context) learning, clinical decision-making, and clinical practice; 3. The dissemination and introduction of the GGP and TGGP in education has been successful so far, but is still not optimal because of lack of support and cooperation. CONCLUSIONS: On the basis of the evaluation results, a plan for the revision of the GGP and TGGP is presented.


Subject(s)
Drug Prescriptions/standards , Education, Medical/standards , Pharmacology, Clinical/standards , Practice Guidelines as Topic , Clinical Decision-Making/methods , Education, Medical/trends , Pharmacology, Clinical/trends , Problem-Based Learning/trends , World Health Organization
7.
QJM ; 112(1): 17-21, 2019 Jan 01.
Article in English | MEDLINE | ID: mdl-30295832

ABSTRACT

AIM: To evaluate prior prevalence of HIV indicator conditions in late-presenters with HIV infection. DESIGN: Retrospective cohort study between 2000 and 2014 in a healthcare network in Melbourne, Australia comparing patients presenting with late diagnosis of HIV infection (CD4 < 350 cells/ml) to those patients who had a CD greater than or equal to 350 cells/ml at presentation. METHOD: The European AIDS Clinical Society guidelines on HIV indicator guided testing were used to assess for any indicator conditions in their prior medical history which may have represented a missed opportunity for earlier diagnosis. Main outcome measures: Descriptive statistics and prevalence of HIV indicator conditions. RESULTS: Of 436 patients with HIV infection, 82 were late presenters. Late presenters were more commonly male (83% vs. 75%, P = 0.11), older (mean age 45 vs. 39 years), born overseas (61% vs. 58%, P = 0.68) and report heterosexual transmission as their exposure risk (51% vs. 31%, P < 0.001). Of 80 patients with late presentation of HIV infection, 54 (55%) had at least one, 29 (36%) at least 2, 12 (15%) at least 3 and 5 (6%) had 4 or more previous HIV indicator conditions which would have triggered HIV testing according to guidelines. The most common indicator conditions were: unexplained loss of weight (31%), herpes zoster (10%), thrombocytopenia or leukopenia (10%), oral or oesophageal candidiasis (10%) and community acquired pneumonia (9%). Twenty patients (25%) had HIV indicator conditions diagnosed at least 12 months before the eventual diagnosis of HIV infection. DISCUSSION/ CONCLUSION: Patients diagnosed with late-presenting HIV often had an HIV indicator condition prior to presentation, presenting a missed opportunity for earlier diagnosis.


Subject(s)
Delayed Diagnosis/statistics & numerical data , HIV Infections/diagnosis , HIV Infections/epidemiology , Adolescent , Adult , Aged , Aged, 80 and over , Australia/epidemiology , CD4 Lymphocyte Count , Candidiasis/complications , Child , Community-Acquired Infections/complications , Early Diagnosis , Female , HIV Infections/complications , Herpes Zoster/complications , Humans , Leukopenia/complications , Male , Middle Aged , Pneumonia/complications , Prevalence , Retrospective Studies , Risk Factors , Thrombocytopenia/complications , Time Factors , Weight Loss , Young Adult
8.
Int Nurs Rev ; 65(4): 586-595, 2018 Dec.
Article in English | MEDLINE | ID: mdl-29571221

ABSTRACT

AIM: The objective of this study was to assess the impact of a simulation workshop on self-efficacy towards teaching for nurse educators in India. Additionally, we sought to revise and validate a tool to measure self-efficacy in teaching for use with a global audience. BACKGROUND: Simulation is an evidence-based teaching and learning method and is increasingly used in nursing education globally. INTRODUCTION: As new technology and teaching methods such as simulation continue to evolve, it is important for new as well as experienced nurse educators globally to have confidence in their teaching skills and abilities. METHODS: The study included (1) instrument revision, and measures of reliability and validation, (2) an 8-h faculty development workshop intervention on simulation, (3) pre- and post-survey of self-efficacy among nurse educators, and (4) investigation of relationship between faculty socio-demographics and degree of self-efficacy. RESULTS: The modified tool showed internal consistency (r = 0.98) and was validated by international faculty experts. There were significant improvements in total self-efficacy (P < 0.001) and subscale scores among nurse educators after the simulation workshop intervention when compared to pre-survey results. No significant relationships were found between socio-demographic variables and degree of self-efficacy. DISCUSSION: Strong self-efficacy in teaching among nurse educators is crucial for effective learning to occur. CONCLUSIONS AND IMPLICATIONS FOR NURSING: Results indicated the simulation workshop was effective in significantly improving self-efficacy towards teaching for nurse educators using an internationally validated tool. IMPLICATIONS FOR NURSING POLICY: The Minister of Health in India recently called for improvements in nursing education. Introducing nursing education on simulation as a teaching method in India and globally to improve self-efficacy among teachers is an example of a strategy towards meeting this call.


Subject(s)
Education, Nursing , Faculty, Nursing/education , Faculty, Nursing/psychology , Self Efficacy , Simulation Training , Teacher Training , Adult , Female , Humans , India , Male , Middle Aged , Reproducibility of Results , Young Adult
9.
Int Nurs Rev ; 64(3): 331-344, 2017 Sep.
Article in English | MEDLINE | ID: mdl-28261789

ABSTRACT

AIM: To provide a unique model for use in guiding global collaboration and policy to upscale nursing and midwifery partnerships. BACKGROUND AND INTRODUCTION: Nurses and midwives across nations need skills reaching beyond the bedside and unit level in today's complex, global, multifaceted healthcare milieu. Thoughtful consideration, research and concomitant development of models to guide appropriate upscaling of nurse and midwifery capacity within and between nations are needed. DISCUSSION: This article explores an integrated global approach to upscaling nurse and midwifery capacity using examples of partnerships between nursing and midwifery programmes across multiple continents. CONCLUSION AND IMPLICATIONS FOR NURSING: Global nurse and midwifery capacity is effectively being developed using a myriad of approaches. A new model is presented to illustrate supports, strategies and activities to achieve intermediate and long-term goals for capacity building through strong and sustainable global partnerships. IMPLICATION FOR NURSING POLICY: Development of global skills can focus the nurse and midwife to influence policy-level decisions. Human resource planning that can impact countrywide provision of health care begins in the preservice setting for both nurses and midwives. A global experience can be a value-added component to the well-rounded education of future nurses. Education during preparation for entry into practice is a strategic way to develop a worldview. Incorporating reflective practice can build skills and shape attitudes to prepare the new nurse to be comfortable as a global healthcare provider. An expanded world view is the springboard to more robust and informed involvement and inclusion in policy-level discussions.


Subject(s)
Capacity Building/organization & administration , Global Health , International Cooperation , Midwifery/organization & administration , Nurse Midwives/organization & administration , Adult , Female , Humans , Male , Middle Aged
11.
J Dent ; 58: 48-53, 2017 Mar.
Article in English | MEDLINE | ID: mdl-28161365

ABSTRACT

OBJECTIVES: To investigate the abrasive effect of the tongue on human enamel loss with and without a prior dietary acid challenge in an in situ model. METHODS: A single centre, single blind, randomly allocated, split mouth, four treatment regimen, in situ study in healthy adult volunteers was undertaken. Twenty four subjects wore two lower intra-oral appliances each fitted with 4 human enamel samples 6h/day for 15 days. The samples were treated with either 50ml orange juice or water for 5min ex vivo 4x/day; prior to being licked or not licked with the subject's tongue for 60s. There were 2 samples per group per subject. Surface loss was measured by contact profilometry. RESULTS: 23 subjects completed the study with no adverse events. The mean loss of enamel at 15days was: 0.08µm for water without licking, 0.10µm with water and licking; 1.55µm with orange juice alone, 3.65µm with orange juice and licking. In the absence of erosive challenge, licking had no detectable effect on enamel loss p=0.28. Without licking, orange juice had a highly significant effect on loss compared to water, p<0.001. Erosive challenge followed by licking more than doubled the loss of enamel p<0.001. CONCLUSIONS: When enamel was exposed to orange juice prior to licking, tissue loss as a result of tongue abrasion of the eroded surface was increased, and double that of the erosive challenge alone. Licking enamel with the tongue had no perceptible effect on enamel loss in the absence of the erosive challenge. CLINICAL SIGNIFICANCE: Enamel wear resulting from tongue abrasion on tooth surfaces softened by acid challenge, can be an unavoidable consequence of oral function. This may account for the pattern of erosive toothwear on palatal and occlusal tooth surfaces, reinforcing the importance of restricting the frequency of dietary acid challenge in susceptible individuals.


Subject(s)
Citrus sinensis/adverse effects , Dental Enamel/drug effects , Fruit and Vegetable Juices/adverse effects , Tongue/physiopathology , Tooth Abrasion/etiology , Tooth Erosion/complications , Adolescent , Adult , Beverages/adverse effects , Dental Enamel/pathology , Dietary Supplements , Female , Humans , Hydrogen-Ion Concentration , Male , Single-Blind Method , Surface Properties , Time Factors , Tooth Erosion/pathology , Water , Young Adult
12.
Vox Sang ; 112(1): 18-24, 2017 Jan.
Article in English | MEDLINE | ID: mdl-28001309

ABSTRACT

BACKGROUND AND OBJECTIVES: Platelet function shows significant inheritance that is at least partially genetically controlled. There is also evidence that the platelet response is stable over time, but there are few studies that have assessed consistency of platelet function over months and years. We aimed to measure platelet function in platelet donors over time in individuals selected from a cohort of 956 donors whose platelet function had been previously characterised. MATERIALS AND METHODS: Platelet function was assessed by flow cytometry, measuring fibrinogen binding and P-selectin expression after stimulation with either cross-linked collagen-related peptide or adenosine 5'-diphosphate. Eighty-nine donors from the Cambridge Platelet Function Cohort whose platelet responses were initially within the lower or upper decile of reactivity were retested between 4 months and five and a half years later. RESULTS: There was moderate-to-high correlation between the initial and repeat platelet function results for all assays (P ≤ 0·007, r2 0·2961-0·7625); furthermore, the range of results observed in the initial low and high responder groups remained significantly different at the time of the second test (P ≤ 0·0005). CONCLUSION: Platelet function remains consistent over time. This implies that this potential influence on quality of donated platelet concentrates will remain essentially constant for a given donor.


Subject(s)
Blood Platelets/metabolism , Platelet Activation/physiology , Adenosine Diphosphate/analysis , Adult , Blood Donors , Blood Platelets/cytology , Carrier Proteins/metabolism , Cohort Studies , Female , Fibrinogen/chemistry , Fibrinogen/metabolism , Flow Cytometry , Humans , Male , Middle Aged , P-Selectin/metabolism , Peptides/metabolism , Platelet Function Tests , Protein Binding
13.
Clin Pharmacol Ther ; 100(6): 685-698, 2016 12.
Article in English | MEDLINE | ID: mdl-27626610

ABSTRACT

The current system of biomedical innovation is unable to keep pace with scientific advancements. We propose to address this gap by reengineering innovation processes to accelerate reliable delivery of products that address unmet medical needs. Adaptive biomedical innovation (ABI) provides an integrative, strategic approach for process innovation. Although the term "ABI" is new, it encompasses fragmented "tools" that have been developed across the global pharmaceutical industry, and could accelerate the evolution of the system through more coordinated application. ABI involves bringing stakeholders together to set shared objectives, foster trust, structure decision-making, and manage expectations through rapid-cycle feedback loops that maximize product knowledge and reduce uncertainty in a continuous, adaptive, and sustainable learning healthcare system. Adaptive decision-making, a core element of ABI, provides a framework for structuring decision-making designed to manage two types of uncertainty - the maturity of scientific and clinical knowledge, and the behaviors of other critical stakeholders.


Subject(s)
Biomedical Research/organization & administration , Decision Making , Delivery of Health Care/organization & administration , Diffusion of Innovation , Drug Industry/organization & administration , Feedback , Health Services Needs and Demand , Humans , Uncertainty
14.
Clin Pharmacol Ther ; 100(6): 633-646, 2016 12.
Article in English | MEDLINE | ID: mdl-27627027

ABSTRACT

Analyses of healthcare databases (claims, electronic health records [EHRs]) are useful supplements to clinical trials for generating evidence on the effectiveness, harm, use, and value of medical products in routine care. A constant stream of data from the routine operation of modern healthcare systems, which can be analyzed in rapid cycles, enables incremental evidence development to support accelerated and appropriate access to innovative medicines. Evidentiary needs by regulators, Health Technology Assessment, payers, clinicians, and patients after marketing authorization comprise (1) monitoring of medication performance in routine care, including the materialized effectiveness, harm, and value; (2) identifying new patient strata with added value or unacceptable harms; and (3) monitoring targeted utilization. Adaptive biomedical innovation (ABI) with rapid cycle database analytics is successfully enabled if evidence is meaningful, valid, expedited, and transparent. These principles will bring rigor and credibility to current efforts to increase research efficiency while upholding evidentiary standards required for effective decision-making in healthcare.


Subject(s)
Biomedical Research/organization & administration , Databases, Factual/statistics & numerical data , Decision Making , Delivery of Health Care/organization & administration , Efficiency, Organizational , Delivery of Health Care/standards , Diffusion of Innovation , Electronic Health Records , Health Services Accessibility , Humans , Technology Assessment, Biomedical
15.
Clin Pharmacol Ther ; 100(6): 594-597, 2016 12.
Article in English | MEDLINE | ID: mdl-27530105

ABSTRACT

Adaptive pathways for medicines have gained momentum and, in Europe, adaptive pathways have recently been introduced into the European Medicines Agency (EMA) processes after a successful 2-year pilot. Although the concept, as initially proposed, contained several elements that would have required regulatory reforms, the adaptive pathways program has developed a more pragmatic scope (Box 1). In this article, we explore the main challenges and opportunities adaptive pathways pose from a European health technology assessment (HTA) perspective.


Subject(s)
Drug Approval/legislation & jurisprudence , Government Agencies , Technology Assessment, Biomedical/methods , Europe , Humans , Pilot Projects
16.
Br J Dermatol ; 174(5): 970-8, 2016 May.
Article in English | MEDLINE | ID: mdl-26801356

ABSTRACT

More than 50 interventions have been used to treat hidradenitis suppurativa (HS), and so therapy decisions can be challenging. Our objective was to summarize and appraise randomized controlled trial (RCT) evidence for HS interventions in adults. Searches were conducted in Medline, Embase, CENTRAL, LILACS, five trials registers and abstracts from eight dermatology conferences until 13 August 2015. Two review authors independently assessed study eligibility, extracted data and assessed methodological quality. Primary outcomes were quality of life and adverse effects of the interventions. Twelve trials, from 1983 to 2015, investigating 15 different interventions met our inclusion criteria. The median trial duration was 16 weeks and the median number of participants was 27. Adalimumab 40 mg weekly improved the Dermatology Life Quality Index (DLQI) by 4·0 points, which equates to the minimal clinically important difference for the scale, compared with placebo (95% confidence interval -6·5 to -1·5 points). Evidence quality was reduced to 'moderate' because the results are based on only a single study. Adalimumab 40 mg every other week was ineffective in a meta-analysis of two studies comprising 124 participants. Infliximab 5 mg kg(-1) improved the DLQI score by 8·4 points after 8 weeks in a moderate-quality study completed by 33 of 38 participants. Etanercept 50 mg twice weekly was ineffective. Inclusion of a gentamicin sponge prior to primary closure did not improve outcomes. Other interventions, including topical and oral antibiotics, were investigated by relatively small studies, preventing treatment recommendations due to imprecision. More, larger RCTs are required to investigate most HS interventions, particularly oral treatments and surgical therapy. Moderate-quality evidence suggests that adalimumab given weekly and infliximab are effective, whereas adalimumab every other week is ineffective.


Subject(s)
Hidradenitis Suppurativa/drug therapy , Adalimumab/administration & dosage , Administration, Oral , Adult , Androgen Antagonists/administration & dosage , Anti-Bacterial Agents/administration & dosage , Clindamycin/administration & dosage , Cyproterone Acetate/administration & dosage , Dermatologic Agents/administration & dosage , Etanercept/administration & dosage , Ethinyl Estradiol/administration & dosage , Gentamicins/administration & dosage , Humans , Infliximab/administration & dosage , Norgestrel/administration & dosage , Quality of Life , Treatment Outcome , Wound Closure Techniques
17.
J Evol Biol ; 29(3): 633-44, 2016 03.
Article in English | MEDLINE | ID: mdl-26688005

ABSTRACT

Disruptive selection is a process that can result in multiple subgroups within a population, which is referred to as diversification. Foraging-related diversification has been described in many taxa, but many questions remain about the contribution of such diversification to reproductive isolation and potentially sympatric speciation. Here, we use stable isotope analysis of diet and morphological analysis of body shape to examine phenotypic divergence between littoral and pelagic foraging ecomorphs in a population of pumpkinseed sunfish (Lepomis gibbosus). We then examine reproductive isolation between ecomorphs by comparing the isotopic compositions of nesting males to eggs from their nests (a proxy for maternal diet) and use nine microsatellite loci to examine genetic divergence between ecomorphs. Our data support the presence of distinct foraging ecomorphs in this population and indicate that there is significant positive assortative mating based on diet. We did not find evidence of genetic divergence between ecomorphs, however, indicating that isolation is either relatively recent or is not strong enough to result in genetic divergence at the microsatellite loci. Based on our findings, pumpkinseed sunfish represent a system in which to further explore the mechanisms by which natural and sexual selection contribute to diversification, prior to the occurrence of sympatric speciation.


Subject(s)
Perciformes/genetics , Polymorphism, Genetic , Sexual Behavior, Animal/physiology , Animals , Biological Evolution , Carbon Isotopes/analysis , Diet , Ecosystem , Female , Male , Microsatellite Repeats , Nesting Behavior , Nitrogen Isotopes/analysis , Ontario , Perciformes/physiology , Sympatry
18.
Clin Pharmacol Ther ; 98(1): 34-46, 2015 Jul.
Article in English | MEDLINE | ID: mdl-25868461

ABSTRACT

The discovery, development, and use of biomarkers for a variety of drug development purposes are areas of tremendous interest and need. Biomarkers can become accepted for use through submission of biomarker data during the drug approval process. Another emerging pathway for acceptance of biomarkers is via the biomarker qualification program developed by the Center for Drug Evaluation and Research (CDER, US Food and Drug Administration). Evidentiary standards are needed to develop and evaluate various types of biomarkers for their intended use and multiple stakeholders, including academia, industry, government, and consortia must work together to help develop this evidence. The article describes various types of biomarkers that can be useful in drug development and evidentiary considerations that are important for qualification. A path forward for coordinating efforts to identify and explore needed biomarkers is proposed for consideration.


Subject(s)
Biomarkers, Pharmacological , Drug Approval , Drug Discovery , Drug Approval/legislation & jurisprudence , Drug Industry/legislation & jurisprudence , United States , United States Food and Drug Administration
19.
J Perinatol ; 35(8): 631-5, 2015 Aug.
Article in English | MEDLINE | ID: mdl-25836318

ABSTRACT

OBJECTIVE: To evaluate the effectiveness of an interactive computerized order set with decision support (ICOS-DS) in preventing medication errors in neonatal late-onset sepsis (LOS). STUDY DESIGN: Prospective, controlled comparison of error rates in antibiotic orders for neonates admitted to the Medical University of South Carolina neonatal intensive care unit with suspected LOS (after postnatal day of life 3) prior to (n=153) and after (n=146) implementation of the ICOS-DS. Antibiotic orders were independently evaluated by two pharmacists for prescribing errors, potential errors and omissions. Prescribing errors included>10% overdoses or underdoses, inappropriate route, schedule or antibiotic, drug-drug or drug-disease interactions, and incorrect patient demographics. Potential errors included misspelled drugs, leading decimals, trailing zeroes, impractical doses and error-prone abbreviations. Multiple errors and omissions in an order were counted individually. RESULTS: Overall error rate per order decreased from 1.7 to 0.8 (P<0.001) and potential error rate from 1.0 to 0.06 (P<0.001). The reduction in omission error rate per order from 0.2 to 0.1 was not significant (P=0.17). The prescribing error rate per order increased from 0.4 to 0.7 (P=0.03) because of the use of incorrect patient weights (P<0.001). Renal dysfunction was significantly associated with an increased risk of prescribing errors (odds ratio=3.7, P=0.01) which was not significantly different for handwritten versus ICOS-DS orders (P=0.15). CONCLUSIONS: The ICOS-DS significantly improved the quality of neonatal LOS antibiotic orders although the use of incorrect patient weights was increased. In both groups, orders for patients with renal dysfunction were at risk for prescribing errors. Further evaluation of interventions to promote medication safety for this population is needed.


Subject(s)
Anti-Bacterial Agents/therapeutic use , Drug Prescriptions/standards , Late Onset Disorders/drug therapy , Medication Errors/prevention & control , Sepsis/drug therapy , Humans , Infant , Infant, Newborn , Intensive Care Units, Neonatal , Practice Guidelines as Topic , Prospective Studies
20.
Clin Pharmacol Ther ; 97(3): 234-46, 2015 Mar.
Article in English | MEDLINE | ID: mdl-25669457

ABSTRACT

The concept of adaptive licensing (AL) has met with considerable interest. Yet some remain skeptical about its feasibility. Others argue that the focus and name of AL should be broadened. Against this background of ongoing debate, we examine the environmental changes that will likely make adaptive pathways the preferred approach in the future. The key drivers include: growing patient demand for timely access to promising therapies, emerging science leading to fragmentation of treatment populations, rising payer influence on product accessibility, and pressure on pharma/investors to ensure sustainability of drug development. We also discuss a number of environmental changes that will enable an adaptive paradigm. A life-span approach to bringing innovation to patients is expected to help address the perceived access vs. evidence trade-off, help de-risk drug development, and lead to better outcomes for patients.


Subject(s)
Drug Approval/legislation & jurisprudence , Drug Approval/methods , Drug Discovery/legislation & jurisprudence , Licensure , Humans
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