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3.
CA Cancer J Clin ; 66(2): 96-114, 2016.
Artículo en Inglés | MEDLINE | ID: mdl-26797525

RESUMEN

Each year the American Cancer Society (ACS) publishes a summary of its guidelines for early cancer detection, data and trends in cancer screening rates, and select issues related to cancer screening. In this issue of the journal, we summarize current ACS cancer screening guidelines, including the update of the breast cancer screening guideline, discuss quality issues in colorectal cancer screening and new developments in lung cancer screening, and provide the latest data on utilization of cancer screening from the National Health Interview Survey.


Asunto(s)
Detección Precoz del Cáncer , Guías como Asunto/normas , Neoplasias/diagnóstico , American Cancer Society , Neoplasias de la Mama/diagnóstico , Colonoscopía/métodos , Neoplasias Colorrectales/diagnóstico , Femenino , Humanos , Neoplasias Pulmonares/diagnóstico , Masculino , Mamografía/métodos , Neoplasias/epidemiología , Neoplasias/prevención & control , Neoplasias Ováricas/diagnóstico , Vacunas contra Papillomavirus/administración & dosificación , Vigilancia de la Población , Prevalencia , Neoplasias de la Próstata/diagnóstico , Estados Unidos/epidemiología , Neoplasias Uterinas/diagnóstico
4.
J Virol ; 95(18): e0111221, 2021 08 25.
Artículo en Inglés | MEDLINE | ID: mdl-34319158

RESUMEN

Starting work in a virology research laboratory as a new technician, graduate student, or postdoc can be complex, intimidating, confusing, and stressful. From laboratory logistics to elemental expectations to scientific specifics, there is much to learn. To help new laboratory members adjust and excel, a series of guidelines for working and thriving in a virology laboratory is presented. While guidelines may be most helpful for new laboratory members, everyone, including principal investigators, is encouraged to use a set of published guidelines as a resource to maximize the time and efforts of all laboratory members. The topics covered here are safety, wellness, balance, teamwork, integrity, reading, research, writing, speaking, and timelines.


Asunto(s)
Guías como Asunto/normas , Laboratorios/normas , Proyectos de Investigación/normas , Investigadores/normas , Virología/normas , Humanos
5.
Med Care ; 60(1): 95-103, 2022 01 01.
Artículo en Inglés | MEDLINE | ID: mdl-34812790

RESUMEN

BACKGROUND: Pilot studies test the feasibility of methods and procedures to be used in larger-scale studies. Although numerous articles describe guidelines for the conduct of pilot studies, few have included specific feasibility indicators or strategies for evaluating multiple aspects of feasibility. In addition, using pilot studies to estimate effect sizes to plan sample sizes for subsequent randomized controlled trials has been challenged; however, there has been little consensus on alternative strategies. METHODS: In Section 1, specific indicators (recruitment, retention, intervention fidelity, acceptability, adherence, and engagement) are presented for feasibility assessment of data collection methods and intervention implementation. Section 1 also highlights the importance of examining feasibility when adapting an intervention tested in mainstream populations to a new more diverse group. In Section 2, statistical and design issues are presented, including sample sizes for pilot studies, estimates of minimally important differences, design effects, confidence intervals (CI) and nonparametric statistics. An in-depth treatment of the limits of effect size estimation as well as process variables is presented. Tables showing CI around parameters are provided. With small samples, effect size, completion and adherence rate estimates will have large CI. CONCLUSION: This commentary offers examples of indicators for evaluating feasibility, and of the limits of effect size estimation in pilot studies. As demonstrated, most pilot studies should not be used to estimate effect sizes, provide power calculations for statistical tests or perform exploratory analyses of efficacy. It is hoped that these guidelines will be useful to those planning pilot/feasibility studies before a larger-scale study.


Asunto(s)
Estudios de Factibilidad , Guías como Asunto/normas , Proyectos Piloto , Proyectos de Investigación/normas , Humanos , Proyectos de Investigación/estadística & datos numéricos
6.
BMC Pregnancy Childbirth ; 22(1): 99, 2022 Feb 04.
Artículo en Inglés | MEDLINE | ID: mdl-35120470

RESUMEN

BACKGROUND: Current guidelines for second stage management do not provide guidance for community birth providers about when best to transfer women to hospital care for prolonged second stage. Our goal was to increase the evidence base for these providers by: 1) describing the lengths of second stage labor in freestanding birth centers, and 2) determining whether proportions of postpartum women and newborns experiencing complications change as length of second stage labor increases. METHODS: This study is a retrospective analysis of de-identified client-level data collected in the American Association of Birth Centers Perinatal Data Registry, including women giving birth in freestanding birth centers January 1, 2007 to December 31, 2016. We plotted proportions of postpartum women and newborns transferred to hospital care against length of the second stage of labor, and assessed significance of these with the Cochran-Armitage test for trend or chi-square test. Secondary maternal and newborn outcomes were compared for dyads with normal and prolonged second stages of labor using Fisher's exact test. RESULTS: Second stage labor exceeded 3 hours for 2.3% of primiparous women and 2 hours for 6.6% of multiparous women. Newborn transfers increased as second stage increased from < 15 minutes to > 2 hours (0.6% to 6.33%, p for trend = 0.0008, for primiparous women, and 1.4% to 10.6%, p for trend < 0.0001, for multiparous women.) Postpartum transfers for multiparous women increased from 1.4% after second stage < 15 minutes to greater than 4% for women after second stage exceeding 2 hours (p for trend < 0.0001.) CONCLUSIONS: Complications requiring hospitalization of postpartum women and newborns become more common as the length of the second stage increases. Birth center guidelines should consider not just presence of progress but also absolute length of time as indications for transfer.


Asunto(s)
Centros de Asistencia al Embarazo y al Parto/normas , Guías como Asunto/normas , Segundo Periodo del Trabajo de Parto , Transferencia de Pacientes/normas , Adulto , Femenino , Humanos , Recién Nacido , Complicaciones del Trabajo de Parto/terapia , Periodo Posparto , Embarazo , Estudios Retrospectivos , Factores de Tiempo , Estados Unidos
7.
J Clin Pharm Ther ; 47(2): 178-183, 2022 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-34668592

RESUMEN

WHAT IS KNOWN AND OBJECTIVE: Robust critical appraisal tools for clinical pharmacokinetic studies are limited. Before development of such a tool is possible, quality markers (items deemed important for credibility of study results) must be identified. We aim to create an inventory of quality markers intended for the appraisal of clinical pharmacokinetic studies and to categorize identified markers into associated domains of study quality. METHODS: Medline via ProQuest central (1946-Sep 2020, EMBASE (1974-Sep 2020), Cochrane database of systematic reviews, Google and Google Scholar were searched using the following search categories: pharmacokinetics, reporting guidelines and quality markers. Reference lists of the identified articles were searched manually. Any article (review, study or guideline) reporting quality markers related to the appraisal of pharmacokinetic literature was eligible for inclusion. Articles were further screened and limited to those reported in English on human subjects only. Cell-based and animal-based pharmacokinetic studies were excluded. Extracted data from included articles included identified or perceived markers of quality and baseline article data. Identified quality markers were then categorized according to manuscript reporting domains (abstract, introduction/background, methodology, results, discussion and conclusion). RESULTS AND DISCUSSION: Of 789 studies identified, 17 articles were included for extraction of quality markers. A total of 35 quality markers were identified across eight categories. The most frequently reported quality markers were related to method (13/35) and result sections (6/35). Quality markers encompassed all aspects of study design and reporting and were both similar and different to established reporting checklists for clinical pharmacokinetic studies. WHAT IS NEW AND CONCLUSION: The inventory of quality markers is now suitable to undergo further testing for inclusion in a tool designed for the appraisal of clinical pharmacokinetic studies.


Asunto(s)
Ensayos Clínicos como Asunto/normas , Guías como Asunto/normas , Publicaciones Periódicas como Asunto/normas , Farmacocinética , Control de Calidad , Lista de Verificación , Exactitud de los Datos , Humanos
8.
J Korean Med Sci ; 37(4): e26, 2022 Jan 24.
Artículo en Inglés | MEDLINE | ID: mdl-35075825

RESUMEN

BACKGROUND: The Korean Academy of Medical Sciences (KAMS) has been utilizing AGREE II to audit the quality of clinical practice guidelines (CPGs) developed in Korea. Monitoring the RIGHT Checklist adherence could help monitor the quality status and discover areas for improvement of CPG development. METHODS: We included 129 CPGs from the past 5 years and assessed each item of the RIGHT Checklist. STATA version 15.0 was used for statistical analysis. RESULTS: Among the seven sections of the RIGHT checklist, sections with a full compliance rate over 60% were 'basic information' (65%) and 'background' (66%). The other sections' mean full compliance rates were 'Evidence' 52%, 'Recommendation' 35%, 'Review and quality assurance' 25% and 'Funding, declaration and management of interest' 17%. Sections with a partial compliance rate over 60% were 'Recommendation' (60%) and 'Funding, declaration and management of interest' (70%). Non-compliance was highest in the 'Review and quality assurance' (17%) domain. In comparison between groups 1 (under median group) and 2 (over median group), group 2 showed a tendency to have multi-stakeholder involvement and present sufficient information on financial resources and conflict of interest declarations. For the CPGs developmental methodology aspect, group 2 provided more pertinent information than group 1 about supporting evidence-making and the process from evidence to recommendation. CONCLUSION: This study evaluated adherence to the RIGHT Checklist of CPGs developed in Korea. It can provide helpful information to develop strategic plans for enhancing the capabilities of developing CPGs in Korea.


Asunto(s)
Guías como Asunto/normas , Cumplimiento y Adherencia al Tratamiento/estadística & datos numéricos , Humanos , República de Corea
9.
Lancet Oncol ; 22(2): 173-181, 2021 02.
Artículo en Inglés | MEDLINE | ID: mdl-33485459

RESUMEN

BACKGROUND: Estimating a population-level benchmark rate for use of surgery in the management of cancer helps to identify treatment gaps, estimate the survival impact of such gaps, and benchmark the workforce and other resources, including budgets, required to meet service needs. A population-based benchmark for use of surgery in high-income settings to inform policy makers and service provision has not been developed but was recommended by the Lancet Oncology Commission on Global Cancer Surgery. We aimed to develop and validate a cancer surgery benchmarking model. METHODS: We examined the latest clinical guidelines from high-income countries (Australia, the UK, the EU, the USA, and Canada) and mapped surgical treatment pathways for 30 malignant cancer sites (19 individual sites and 11 grouped as other cancers) that were notifiable in Australia in 2014, broadly reflecting contemporary high-income models of care. The optimal use of surgery was considered as an indication for surgery where surgery is the treatment of choice for a given clinical scenario. Population-based epidemiological data, such as cancer stage, tumour characteristics, and fitness for surgery, were derived from Australia and other similar high-income settings for 2017. The probabilities across the clinical pathways of each cancer were multiplied and added together to estimate the population-level benchmark rates of cancer surgery, and further validated with the comparisons of observed rates of cancer surgery in the South Western Sydney Local Health District in 2006-12. Univariable and multivariable sensitivity analyses were done to explore uncertainty around model inputs, with mean (95% CI) benchmark surgery rates estimated on the basis of 10 000 Monte Carlo simulations. FINDINGS: Surgical treatment was indicated in 58% (95% CI 57-59) of newly diagnosed patients with cancer in Australia in 2014 at least once during the course of their treatment, but varied by site from 23% (17-27) for prostate cancer to 99% (96-99) for testicular cancer. Observed cancer surgery rates in South Western Sydney were comparable to the benchmarks for most cancers, but were higher for some cancers, such as prostate (absolute increase of 29%) and lower for others, such as lung (-14%). INTERPRETATION: The model provides a new template for high-income and emerging economies to rationally plan and assess their cancer surgery provision. There are differences in modelled versus observed surgery rates for some cancers, requiring more in-depth analysis of the observed differences. FUNDING: University of New South Wales Scientia Scholarship, UK Research and Innovation-Global Challenges Research Fund.


Asunto(s)
Países Desarrollados/economía , Neoplasias de Células Germinales y Embrionarias/economía , Neoplasias/economía , Neoplasias Testiculares/economía , Australia/epidemiología , Benchmarking/economía , Canadá/epidemiología , Manejo de Datos , Guías como Asunto/normas , Humanos , Neoplasias/epidemiología , Neoplasias/cirugía , Neoplasias de Células Germinales y Embrionarias/epidemiología , Neoplasias Testiculares/epidemiología , Reino Unido/epidemiología
10.
Am J Physiol Cell Physiol ; 320(5): C742-C749, 2021 05 01.
Artículo en Inglés | MEDLINE | ID: mdl-33656929

RESUMEN

Integrating sex as an important biological variable is imperative to enhance the accuracy and reproducibility of cell-based studies, which provide basic information for subsequent preclinical and clinical study designs. Recently, international funding agencies and renowned journals have been attempting to integrate sex as a variable in every research step. To understand what progress has been made in reporting of cell sex in the articles published in AJP-Cell Physiology since the analysis in 2013, we examined the sex notation of the cells in relevant articles published in the same journal in 2018. Of the 107 articles reporting cell experiments, 53 reported the sex of the cells, 18 used both male and female cells, 23 used male cells only, and 12 used female cells only. Sex omission was more frequent when cell lines were used than when primary cells were used. In the articles describing experiments performed using rodent primary cells, more than half of the studies used only male cells. Our results showed an overall improvement in sex reporting for cells in AJP-Cell Physiology articles from 2013 (25%) to 2018 (50%). However, sex omission and male bias were often found still. Furthermore, the obtained results were rarely analyzed by sex even when both male and female cells were used in the experiments. To boost sex-considerate research implementation in basic biomedical studies, cooperative efforts of the research community, funders, and publishers are urged.


Asunto(s)
Sesgo , Publicaciones Periódicas como Asunto/normas , Proyectos de Investigación/normas , Caracteres Sexuales , Animales , Línea Celular , Lista de Verificación/normas , Políticas Editoriales , Femenino , Guías como Asunto/normas , Humanos , Masculino , Cultivo Primario de Células , Factores Sexuales
11.
PLoS Med ; 18(10): e1003793, 2021 10.
Artículo en Inglés | MEDLINE | ID: mdl-34665805

RESUMEN

BACKGROUND: The importance of infectious disease epidemic forecasting and prediction research is underscored by decades of communicable disease outbreaks, including COVID-19. Unlike other fields of medical research, such as clinical trials and systematic reviews, no reporting guidelines exist for reporting epidemic forecasting and prediction research despite their utility. We therefore developed the EPIFORGE checklist, a guideline for standardized reporting of epidemic forecasting research. METHODS AND FINDINGS: We developed this checklist using a best-practice process for development of reporting guidelines, involving a Delphi process and broad consultation with an international panel of infectious disease modelers and model end users. The objectives of these guidelines are to improve the consistency, reproducibility, comparability, and quality of epidemic forecasting reporting. The guidelines are not designed to advise scientists on how to perform epidemic forecasting and prediction research, but rather to serve as a standard for reporting critical methodological details of such studies. CONCLUSIONS: These guidelines have been submitted to the EQUATOR network, in addition to hosting by other dedicated webpages to facilitate feedback and journal endorsement.


Asunto(s)
Investigación Biomédica/normas , COVID-19/epidemiología , Lista de Verificación/normas , Epidemias , Guías como Asunto/normas , Proyectos de Investigación , Investigación Biomédica/métodos , Lista de Verificación/métodos , Enfermedades Transmisibles/epidemiología , Epidemias/estadística & datos numéricos , Predicción/métodos , Humanos , Reproducibilidad de los Resultados
12.
Med Care ; 59(12): 1122-1129, 2021 12 01.
Artículo en Inglés | MEDLINE | ID: mdl-34779795

RESUMEN

BACKGROUND: Patient-level and community-level social and economic conditions impact hypertension risk and control. We examined adult hypertension management guidelines to explore whether and how existing guidelines refer to social care activities. OBJECTIVE: The objective of this study was to explore how hypertension guidelines reference social care activities. RESEARCH DESIGN: A systematic scoping review of clinical guidelines for adult hypertension management. We employed a PubMed search strategy to identify all hypertension guidelines published in the United States between 1977 and 2019. We reviewed all titles to identify the most updated versions focused on nonpregnant adults with hypertension. We extracted instances where guidelines referred to social determinants of health (SDH) or social care activities. The primary outcome was how guidelines covered social care activities, defined using a framework adapted from the National Academies of Sciences, Engineering, and Medicine (NASEM). RESULTS: Search terms yielded 126 guidelines. Thirty-six guidelines met the inclusion criteria. Of those, 72% (26/36) recommended social care activities as part of hypertension management; 58% recommended clinicians change clinical practice based on social risk information. These recommendations often lacked specific guidance around how to directly address social risk factors or reduce the impact of these risks on hypertension management. When guidelines referred to specific social factors, patient financial security was the most common. Over time, hypertension guidelines have included more references to SDH. CONCLUSION: Information about SDH is included in many hypertension guidelines, but few guidelines provide clear guidance for clinicians or health systems on how to identify and address social risk factors in the context of care delivery.


Asunto(s)
Guías como Asunto/normas , Hipertensión/terapia , Determinantes Sociales de la Salud , Humanos
13.
Med Care ; 59(1): e1-e8, 2021 01.
Artículo en Inglés | MEDLINE | ID: mdl-33165149

RESUMEN

OBJECTIVE: The objective of this study was to examine the potential impact of provider social networks and experiences with patients on deimplementation of breast cancer screening. RESEARCH DESIGN: We constructed the Breast Cancer-Social network Agent-based Model (BC-SAM), which depicts breast cancer screening decisions, incidence, and progression among 10,000 women ages 40 and over and the screening recommendations of their providers over a 30-year period. The model has patient and provider modules that each incorporate social network influences. Patients and providers were connected in a network, which represented patient-patient peer connections, provider-provider peer connections, connections between providers and patients they treat, and friend/family relationships between patients and providers. We calibrated provider decisions in the model using data from the CanSNET national survey of primary care physicians in the United States, which we fielded in 2016. RESULTS: First, assuming that providers' screening recommendations for women ages 50-74 remain unchanged but their recommendations for screening among younger (below 50 y old) and older (75+ y old) women decrease, we observed a decline in predicted screening rates for women ages 50-74 due to spillover effects. Second, screening rates for younger and older women were slow to respond to changes in provider recommendations; a 78% decline in provider recommendations to older women over 30 years resulted in an estimated 23% decline in patient screening in that group. Third, providers' experiences with unscreened patients, friends, and family members modestly increased screening recommendations over time (7 percentage points). Finally, we found that provider peer effects can have a substantial impact on population screening rates and can entrench existing practices. CONCLUSION: Modeling cancer screening as a complex social system demonstrates a range of potential effects and may help target future interventions designed to reduce overscreening.


Asunto(s)
Neoplasias de la Mama/diagnóstico , Detección Precoz del Cáncer/estadística & datos numéricos , Guías como Asunto/normas , Pautas de la Práctica en Medicina/estadística & datos numéricos , Red Social , Adulto , Anciano , Femenino , Humanos , Estudios Longitudinales , Persona de Mediana Edad , Médicos de Atención Primaria , Estados Unidos
14.
Int J Legal Med ; 135(5): 1965-1981, 2021 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-33594456

RESUMEN

Between the ever-increasing availability of surveillance evidence and expert-based forensic facial comparison being considered admissible in court, confirming its validity is paramount. Facial comparison is most commonly conducted using morphological analysis (MA), a largely untested feature-based approach. This study aimed at validating the current recommended practice of MA in both standardised and suboptimal surveillance samples. Face pools of 175 South African males were compiled with a series of facial photographs, using images from the Wits Face Database. The first 75 face pools consisted of wildtype (unstandardised) high-quality target photographs, while the remaining 100 face pools consisted of suboptimal closed-circuit television (CCTV) target images. Target images were compared to high-quality standardised photographs. Face pools were analysed using the Facial Identification Scientific Working Group's guidelines and feature list. Confusion matrices were used to determine the performance of MA in each cohort. MA was found highly accurate (chance-corrected accuracy (CCA): 99.1%) and reliable (κ = 0.921) in the photographic sample and less accurate (CCA: 82.6%) and reliable (κ = 0.743), in the CCTV sample. Higher false-positive and false-negative rates were noted for the CCTV sample, with the majority of errors resulting in false-negative outcomes. The decreased performance in the CCTV sample was attributed to various factors including image quality, angle of recording and lighting. Other studies testing facial comparison identified lower accuracies and reliability across various conditions. Better performance was found here and in other studies that included some form of facial feature list, reinforcing the importance of using a systematic facial feature list.


Asunto(s)
Reconocimiento Facial , Ciencias Forenses/métodos , Guías como Asunto/normas , Fotograbar , Televisión , Grabación en Video , Adulto , Bases de Datos Factuales , Humanos , Masculino , Valor Predictivo de las Pruebas , Sensibilidad y Especificidad , Sudáfrica
15.
BMC Pregnancy Childbirth ; 21(1): 528, 2021 Jul 24.
Artículo en Inglés | MEDLINE | ID: mdl-34303351

RESUMEN

BACKGROUND: Antepartum stillbirth, i.e., intrauterine fetal death (IUFD) above 24 weeks of gestation, occurs with a prevalence of 2.4-3.1 per 1000 live births in Central Europe. In order to ensure highest standards of treatment and identify causative and associated (risk) factors for fetal death, evidence-based guidelines on clinical practice in such events are recommended. Owing to a lack of a national guideline on maternal care and investigations following stillbirth, we, hereby, sought to assess the use of institutional guidelines and clinical practice after IUFD in Austrian maternity units. METHODS: A national survey with a paper-based 12-item questionnaire covering demographic variables, local facilities and practice, obstetrical care and routine post-mortem work-up following IUFD was performed among all Austrian secondary and tertiary referral hospitals with maternity units (n = 75) between January and July 2019. Statistical tests were conducted using Chi2 and Fisher's Exact test, respectively. Univariate logistic regression analyses were performed to calculate odds ratio (OR) with a 95% confidence interval (CI). RESULTS: 46 (61.3%) obstetrical departments [37 (80.4%) secondary; 9 (19.6%) tertiary referral hospitals] participated in this survey, of which 17 (37.0%) have implemented an institutional guideline. The three most common investigations always conducted following stillbirth are placental histology (20.9%), fetal autopsy (13.1%) and maternal antibody screen (11.5%). Availability of an institutional guideline was not significantly associated with type of hospital, on-site pathology department, or institutional annual live and stillbirth rates. Post-mortem consultations only in cases of abnormal investigations following stillbirth were associated with lower odds for presence of such guideline [OR 0.133 (95% CI 0.018-0.978); p = 0.047]. 26 (56.5%) departments consider a national guideline necessary. CONCLUSIONS: Less than half of the surveyed maternity units have implemented an institutional guideline on maternal care and investigations following antepartum stillbirth, independent of annual live and stillbirth rate or type of referral centre.


Asunto(s)
Guías como Asunto/normas , Instituciones de Salud/normas , Servicios de Salud Materna/normas , Mortinato/epidemiología , Austria , Autopsia , Femenino , Edad Gestacional , Humanos , Edad Materna , Placenta , Embarazo , Factores de Riesgo , Encuestas y Cuestionarios
16.
BMC Pregnancy Childbirth ; 21(1): 720, 2021 Oct 26.
Artículo en Inglés | MEDLINE | ID: mdl-34702198

RESUMEN

BACKGROUND: The meaningful engagement of male partners in antenatal care (ANC) can positively impact maternal and newborn health outcomes. The Tanzania National Plan for the Elimination of Mother to Child Transmission of HIV recommends male partners attend the first ANC appointment as a strategy for HIV prevention and treatment. This recommendation seeks to increase uptake of HIV and reproductive healthcare services, but unintended consequences of these guidelines may negatively impact women's ANC experiences. This study qualitatively examined the impact of policy promoting male engagement on women's ANC experiences. METHODS: The study was conducted in two urban clinics in Kilimanjaro Region, Tanzania. In-depth interviews were conducted with 19 participants (13 women and 6 male partners) attending a first ANC appointment. A semi-structured guide was developed, applying Kabeer's Social Relations Approach. Data were analyzed using applied thematic analysis, combining memo writing, coding, synthesis, and comparison of themes. RESULTS: Male attendance impacted the timing of women's presentation to ANC and experience during the first ANC visit. Women whose partners could not attend delayed their presentation to first ANC due to fears of being interrogated or denied care because of their partner absence. Women presenting with partners were given preferential treatment by clinic staff, and women without partners felt discriminated against. Women perceived that the clinic prioritized men's HIV testing over involvement in pregnancy care. CONCLUSIONS: Study findings indicate the need to better assess and understand the unintended impact of policies promoting male partner attendance at ANC. Although male engagement can benefit the health outcomes of mothers and newborn children, our findings demonstrate the need for improved methods of engaging men in ANC. ANC clinics should identify ways to make clinic settings more male friendly, utilize male attendance as an opportunity to educate and engage men in pregnancy and newborn care. At the same time, clinic policies should be cognizant to not discriminate against women presenting without a partner.


Asunto(s)
Atención Ambulatoria/normas , Participación del Paciente/psicología , Mujeres Embarazadas/psicología , Atención Prenatal/normas , Esposos , Adulto , Femenino , Guías como Asunto/normas , Humanos , Masculino , Persona de Mediana Edad , Políticas , Embarazo , Investigación Cualitativa , Tanzanía , Servicios Urbanos de Salud
17.
Am J Emerg Med ; 49: 233-239, 2021 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-34146922

RESUMEN

OBJECTIVES: The purpose of this study was to describe the design and impact of a point-of-care ultrasound (PoCUS) workflow integrated into the electronic medical record (EMR) on PoCUS utilization, documentation compliance, and resultant revenue potential. METHODS: This was a single-center retrospective study at an academic center. The study period spanned from December 1, 2018 to June 30, 2019 (pre-implementation) to August 1, 2019 to February 29, 2020 (post-implementation). The implementation date was July 11, 2019 at which time a PoCUS workflow was integrated into the EMR in the emergency department without the purchase of middleware. Prior to this new workflow, a non-automated workflow was in place. PoCUS scan data were extracted from the EMR and archived examinations. The mean number of PoCUS examinations performed per month per 100 ED visits before and after implementation of the new workflow were compared using an unpaired t-test, stratified by all health care professionals, and attending physicians alone. The rate of documentation compliance before and after implementation of the new workflow were compared using a chi square contingency test. Potential revenue was calculated for each period by multiplying the number of eligible examinations by the respective 2020 Medicare conversion factor Relative Value Units. RESULTS: Utilization of PoCUS from pre-implementation to post-implementation increased 28.7% from 5.01 to 6.45 mean examinations per month per 100 ED visits by all health care professionals (p = 0.063), and 75.1% from 2.01 to 3.52 by attending physicians (p = 0.0001). Examinations in compliance with workflow requirements increased from 153 (14.7%) to 1307 (94.0%). The rate of workflow compliance improved from 14.7% to 94.0% of examinations (p < 0.0001). Potential revenue increased from $546.01 to $22,014.47. CONCLUSIONS: The implementation of a middleware-free PoCUS workflow at our institution was associated with increased PoCUS utilization, documentation compliance, and potential revenue.


Asunto(s)
Guías como Asunto/normas , Ultrasonografía/métodos , Adhesión a Directriz , Humanos , Sistemas de Atención de Punto/economía , Sistemas de Atención de Punto/normas , Sistemas de Atención de Punto/estadística & datos numéricos , Ultrasonografía/economía , Ultrasonografía/instrumentación
18.
Regul Toxicol Pharmacol ; 127: 105052, 2021 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-34653552

RESUMEN

The "SCCS Notes of Guidance for the Testing of Cosmetic Ingredients and Their Safety Evaluation, 11 th Revision" (SCCS/1628/21) contains relevant and updated information on the different aspects of testing and safety evaluation of cosmetic substances in Europe. The emphasis is on cosmetic ingredients for which a concern has been expressed for human health. Indirectly, the Guidance also provides some advice on the safety of finished products. A general aim is to improve harmonised compliance with the current cosmetic EU legislation, Regulation (EC) No 1223/2009, for which animal testing and marketing bans fully apply from 2013 onwards. This means that no in vivo testing of ingredients or finished products is allowed in Europe for the purpose of cosmetics. For this reason, the SCCS has closely followed the progress made in regard to the development and validation of alternative replacement methods, also referred to as new approach methodology (NAM). The "SCCS Notes of Guidance" are regularly revised and updated in order to incorporate progress made and experience gained over time, in particular on the use of NAMs, and the new methods and data that became available since previous revision (SCCS/1602/18) formed the basis of the current (11 th) Revision.


Asunto(s)
Alternativas a las Pruebas en Animales/métodos , Seguridad de Productos para el Consumidor/normas , Cosméticos/normas , Guías como Asunto/normas , Alternativas a las Pruebas en Animales/normas , Europa (Continente) , Humanos , Medición de Riesgo
19.
Regul Toxicol Pharmacol ; 126: 105023, 2021 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-34363920

RESUMEN

The presence of impurities in drugs is unavoidable. As impurities offer no direct benefit to the patient, it is critical that impurities do not compromise patient safety. Current guidelines on the derivation of acceptable impurity levels leave aspects of calculations open for interpretation, resulting in inconsistencies across industry and regulators. To understand current impurity qualification practices from a safety standpoint, regulatory expectations and the safety risk that impurities pose, the IQ DruSafe Impurities Working Group (WG) conducted a pharmaceutical industry-wide survey. Survey results highlighted areas that could benefit from harmonization, including nonclinical species/sex selection and the application of adjustment factors (i.e., body surface area). Recommendations for alignment on these topics is included in this publication. Additionally, the WG collated repeat-dose toxicity information for 181 starting materials and intermediates, reflective of pharmaceutical impurities, to understand the toxicological risks they generally pose in relation to the drug substance (DS) and the assumptions surrounding the calculation of qualified impurity levels. An evaluation of this dataset and the survey were used to harmonize how to calculate a safe limit for an impurity based on toxicology testing of the impurity when present within the DS.


Asunto(s)
Contaminación de Medicamentos , Industria Farmacéutica/normas , Guías como Asunto/normas , Internacionalidad , Bases de Datos Factuales , Relación Dosis-Respuesta a Droga , Humanos , Modelos Animales , Seguridad del Paciente , Medición de Riesgo , Pruebas de Toxicidad/normas
20.
Postgrad Med J ; 97(1154): 782-788, 2021 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-33008956

RESUMEN

BACKGROUND: The number of different antimicrobial recommendations between hospital trusts for the same indication in England is unknown. AIM: We aimed to evaluate the heterogeneity of antimicrobial recommendations for seven common inpatient infections across hospital trusts in England and evaluate changes to recommendations following introduction of national (National Institute for Healthcare and Excellence, NICE) and international (WHO) antimicrobial guidelines. METHODS: Guidelines published on the MicroGuide smartphone application were collected from December 2017 to February 2018 and re-evaluated between December 2019 and February 2020. The following indications were assessed: community-acquired pneumonia (CAP) CURB65 score ≥3, hospital-acquired pneumonia (HAP), infective exacerbation of chronic obstructive pulmonary disease (iCOPD), cellulitis, uncomplicated urinary tract infection (uUTI), intra-abdominal infection (IAI) and sepsis of unknown source (SUS). On follow-up, compliance against WHO WATCH antibiotic and NICE recommendations was evaluated. RESULTS: Guidelines were obtained predominantly from England. Antibiotic regimens between hospitals became increasingly diverse across indications in the following order: uUTI, cellulitis, iCOPD, CAP, HAP, IAI and SUS. A piperacillin/tazobactam-based regimen was recommended in HAP (59%), SUS (39%) and IAI (30%). After 2 years, 107 changes were made to 357 antibiotic regimen recommendations; the overall number of regimens using piperacillin-tazobactam and WHO WATCH antibiotics remained similar. Compliance of recommendations with NICE guidelines as follows: iCOPD (100% adherent), uUTI (98%), cellulitis (90%), CAP (43%) and HAP (27%). CONCLUSION: The heterogeneity of antibiotic recommendations increased as the indicated infection was more severe, with broader underlying bacterial causes. Piperacillin-tazobactam remains favoured in antibiotic regimens, despite not recommended in WHO and NICE guidance.


Asunto(s)
Antibacterianos/uso terapéutico , Infección Hospitalaria/tratamiento farmacológico , Guías como Asunto/normas , Pacientes Internos , Infección Hospitalaria/microbiología , Inglaterra , Hospitales , Humanos
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