Metodología para la confección de la guía de tratamiento integral del cáncer de pulmón, en Villa Clara / Methodology to prepare a comprehensive treatment guideline for lung cancer in Villa Clara

RESUMEN Introducción: En Cuba, la Estrategia Nacional de Control del Cáncer recomienda contextualizar las guías clínicas de diagnóstico y tratamiento a las condiciones específicas de cada provincia e institución sanitaria. Objetivo: Describir la metodología para la elaboración de la guía de diagnóstico y tratamiento del cáncer de pulmón en Villa Clara. Métodos: Se realizó una búsqueda bibliográfica en la Biblioteca Cochrane de revisiones sistemáticas y en la base de datos PubMed, en el periodo de 2007-2017. Se consultaron, además, las principales guías nacionales e internacionales relacionadas con el tratamiento del cáncer de pulmón. Se utilizó el consenso de expertos como sistemática de trabajo para la elaboración y validación de la guía. Resultados: Se estructuró un documento final en seis apartados (estadísticas de cáncer de pulmón, prevención y epidemiología, diagnóstico y tratamiento, seguimiento, conducta en la recidiva local y progresión de la enfermedad); con anexos relacionados con la pesquisa, descripción clínica, esquemas de tratamiento, instrumentos de calidad de vida e indicadores. La guía se encuentra implementada en hospitales y policlínicos de la provincia, desde el año 2013, y fue actualizada en 2017. Conclusiones: Esta guía fomenta la valoración multidisciplinaria de los pacientes, orienta a la Atención Primaria de Salud en la aplicación del algoritmo para la atención integral a los enfermos y el desarrollo de los ensayos clínicos con inmunoterapias, e incorpora indicadores de evaluación de desempeño en la red de atención médica.

ABSTRACT Introduction: the National Cancer Control Strategy, in Cuba, recommends contextualizing clinical guidelines for the diagnosis and treatment of the specific conditions in each health institution and province. Objective: to describe the methodology for the preparation of a diagnosis and treatment guideline for lung cancer in Villa Clara. Methods: a bibliographic search was carried out in the Cochrane Library of systematic reviews and in PubMed database, in 2007-2017. The main national and international guidelines related to the treatment of lung cancer were also consulted. The consensus of experts was used as a work system for the guideline preparation and validation. Results: a final document was structured in six sections (lung cancer statistics, prevention and epidemiology, diagnosis and treatment, follow-up, conduct in local recurrence and disease progression); with annexes related to the research, clinical description, treatment schemes, quality of life instruments and indicators. The guideline has been implemented in hospitals and polyclinics in the province since 2013, and was updated in 2017. Conclusions: this guideline promotes the multidisciplinary assessment of patients, guides Primary Health Care in the application of the algorithm for comprehensive care of patients and the development of clinical trials with immunotherapies, as well as incorporates performance evaluation indicators in the health care network.

Sample size, study length, and inadequate controls were the most common self-acknowledged limitations in manual therapy trials: A methodological review.

OBJECTIVES: The aim of this study was to quantify and analyze the presence and type of self-acknowledged limitations (SALs) in a sample of manual therapy (MT) randomized controlled trials. STUDY DESIGN AND SETTING: We randomly selected 120 MT trials. We extracted data related to SALs from the original reports and classified them into 12 categories. After data extraction, specific limitations within each category were identified. A descriptive analysis was performed using frequencies and percentages for qualitative variables. RESULTS: The number of SALs per trial article ranged from 0 to 8, and more than two-thirds of trials acknowledged at least two different limitations. Despite its small proportion, 9% of trials did not report SALs. The most common limitation declared, in almost half of our sample, related to sample size (47.5%) followed by limitations related to study length and follow-up (33.3%) and inadequate controls (32.5%). CONCLUSION: Our results indicate that at least two different limitations are consistently acknowledged in MT trial reports, the most common being those related to sample size, study length, follow-up, and inadequate controls. Analysis of the reasons behind the SALs gives some insights about the main difficulties in conducting research in this field and may help develop strategies to improve future research.

Polish Society of Gynecologists and Obstetricians recommendations on supplementation during pregnancy.

Polish Society of Gynecologists and Obstetricians recommendations on supplementation during pregnancy.

A methodological review revealed that reporting of trials in manual therapy has not improved over time.

OBJECTIVE: The aim of this review was to evaluate a selection of major reporting aspects in manual therapy (MT) trials, before and after the publication of the CONSORT extension for nonpharmacological trials (CONSORTnpt) STUDY DESIGN AND SETTING: We randomly selected 100 MT trials published between 2000 and 2015 and divided them into a pre-CONSORTnpt (n = 50) and a post-CONSORTnpt (n = 50) group. We extracted data on relevant issues of internal validity, reliability, and description of interventions. Two authors extracted data independently. Percentages were used for descriptive analyses, and Fisher's exact test and the chi-square test were used for group comparisons. RESULTS: Six different types of MT interventions with up to 20 controls were analyzed. The most common populations/conditions studied were healthy subjects and subjects with lower back or neck pain. Over 70% of studies included multi-session interventions, and 42% of studies reported long-term followup. The only significant differences between groups were the inclusion of a flowchart diagram, the estimated effect size, precision descriptions, and the description of intervention procedures. CONCLUSION: Our findings suggest that trials in MT show poor reporting even after the availability of standardized guidelines.

Integrated care pathways on dementia in Italy: a survey testing the compliance with a national guidance.

Dementias are chronic, degenerative neurological disorders with a complex management that require the cooperation of different healthcare professionals. The Italian Ministry of Health produced the document "Guidance on Integrated Care pathway for People with Dementia" (GICPD) with the specific objective of providing a standardized framework for the definition, development, and implementation of integrated care pathways (ICP) dedicated to people with dementia. We searched all available Italian territorial ICPs. Two raters assessed the retrieved ICPs with a 2-point scale on a 43-item checklist based on the GICPD. Only 5 out of 21 regions and 5 out of 101 local health authorities had an ICP, with most ICPs having a moderate compliance to the GICPD, in particular for the items referring to the development and implementation of the care pathways. A low to moderate inter-rater agreement was observed, mainly due to a lack of standardized models to describe ICPs for dementias. Results suggest that policy- and decision-makers should pay more attention to the GICPD when producing ICPs. The direct communication with clinicians, and the implementation of more precise and appropriate clinical outcomes, could increase the involvement of clinicians, whose participation is crucial to guarantee that ICPs meet needs of patients and their carers.

Evidence on nutritional therapy practice guidelines and implementation in adult critically ill patients: A systematic scoping review.

BACKGROUND: The rapid increase in disease-related malnutrition makes it almost impossible for healthcare practitioners and policymakers to keep up with its negative consequences. Consequently, healthcare organisations and decision-makers have called for accelerated and double-duty actions to manage the double burden of malnutrition. Guidelines standardise nutritional practices, improve nutritional status and reduce hospitalisation duration and save costs. OBJECTIVES: A systematic scoping review of the nutritional therapy practice guidelines and implementation in critically ill adults was undertaken to identify the breadth of literature on the topic, summarise findings and identify gaps. METHODS: A comprehensive search strategy was designed and implemented to identify eligible studies from eight databases, websites of organisations, government departments and academic platforms. Reference lists of included studies were also searched for relevant studies. We assessed the quality of included studies, completed a descriptive numerical summary and analysed them. RESULTS: In total, 1555 titles and 101 abstracts were screened, 65 underwent full text review and 19 were retained for data extraction. Studies scored average to high on quality assessment, and a summary of characteristics of included studies is presented. Nutritional therapy practice guidelines are considered a proactive strategy for enhanced, uniform and individualised nutritional practices and factors that influence implementation were identified. CONCLUSIONS: A gap exists between research recommendations and actual practice despite the growing interest in implementation of nutritional therapy guidelines in critical care. There is a need for more research to evaluate the practicality of available guidelines.

Adapting the 2015 Mother-Baby Friendly Birth Facility Guidelines for Semi-nomadic Pastoralist Communities in Laikipia and Samburu Counties of Kenya.

Purpose To adapt the 2015 International Federation of Gynecologists and Obstetricians (FIGO), International Confederation of Midwives (ICM), White Ribbon Alliance (WRA), International Pediatric Association (IPA), and WHO auspiced Guidelines on Mother-Baby Friendly Facilities to a particular sub-population; seminomadic pastoralist communities of Laikipia and Samburu Counties, Kenya. We anticipate an increased utilization of childbirth services by improving their acceptability. Description We drafted a Pastoralist Friendly Birthing Facility Checklist based on the FIGO/ICM/WRA/IPA/WHO guidelines and previous research in this context. We employed mixed methods to finalise the adaptation: a workshop with 27 local stakeholders; interviews with ten health planners and skilled birth attendants (SBAs); and ten focus group discussions (FGDs) with health committee members, community health workers, mothers and traditional birth attendants (TBAs). A facility audit of dispensaries across five group ranches was also undertaken. Assessment The final Checklist was divided into: characteristics of care and the environment; care during labour and birth; post-partum care; and community staff relationships. It was endorsed by the Ministries of Health in the relevant counties, and by women, SBAs and TBAs. No facility currently satisfies all the criteria specified in the Checklist. Conclusion The FIGO/ICM/WRA/IPA/WHO Guidelines were successfully adapted and can be used to ensure health facilities meet the needs of pastoralist women.

Current Practices of Live Discharge from Hospice: Social Work Perspectives.

Hospice provides holistic support for individuals living with terminal illness and to their caregivers during the bereavement period. However, some individuals who enroll in hospice services are decertified as they do not experience a decline in health as quickly as required by current regulations, a practice referred to as a live discharge. The interruption in care can affect the physical and psychosocial care needs for individuals and caregivers and leave hospice clinicians with questions about how to best support them. However, there are no formal guidelines to support this process. This qualitative study (N = 24) explored the current practices of hospice social workers across the United States engaged in the live discharge process. Results from this study emphasize the need to bridge the gaps between policy and practice. Specifically, results highlight the challenges hospice social workers face to replicate or supplement the holistic support and unique services hospice provides for individuals discharged alive, and suggest further research to develop live discharge guidelines to identify appropriate support for patients and their caregivers who no longer meet hospice eligibility requirements.

Evidence Underlying Recommendations and Payments from Industry to Authors of the National Comprehensive Cancer Network Guidelines.

BACKGROUND: The National Comprehensive Cancer Network (NCCN) guidelines are among the most widely used guidance in oncology. It is critical to understand the extent to which the recommendations in these guidelines are supported by evidence and to investigate whether these recommendations have been influenced by payments from industry to authors. MATERIALS AND METHODS: We examined the quality and consistency of evidence, as scored by guidelines authors, for systemic treatment incorporated in the NCCN guidelines. Payments data in 2015 were manually abstracted using the Open Payments database, which discloses all payments between the industry and American physicians. Correlations between the percentage of authors who received payments and the proportion of recommendations developed from low-level evidence per guideline were calculated using Spearman rank correlation. RESULTS: In total, 1,782 recommendations were identified in 29 guidelines, of which 1,282 (71.9%) were based on low-quality or low-consistency evidence (low-level evidence), including "case reports or clinical experience only" (18.9%). A substantial proportion (31/143, 21.7%) of category 1 (the highest level) recommendations were based on low-level evidence. The majority of authors (87.1%) received payments from industry. However, no association was found between the prevalence of payments among authors and the percentage of recommendations developed from low-level evidence per guideline. CONCLUSION: The majority of systemic treatment recommendations in the NCCN guidelines are based on low-level evidence, including more than one in five category 1 recommendations. Payments from industry were prevalent among authors. However, industrial payments among authors were not associated with inclusion of regimen/agent for which there is no conclusive evidence in the guidelines. IMPLICATIONS FOR PRACTICE: The authors found that the majority (71.9%) of systemic treatment recommendations issued in the current National Comprehensive Cancer Network guidelines were based on low-level evidence. Physicians should remain cautious when using current guidelines as the sole source guiding patient care decisions.

CE: Breast Cancer Screening: A Review of Current Guidelines.

: Breast cancer accounts for more than a quarter million diagnoses each year in the United States. Routine screening is the primary method used to detect cancer in its earliest stages, before symptoms develop. Recent changes to national screening guidelines have resulted in a lack of consensus and confusion among health care providers and the public. This article reviews the guidelines of the American Cancer Society, the U.S. Preventive Services Task Force, and the National Comprehensive Cancer Network and provides guidance to nurses as they support and educate patients.

Is the content of guidelines/pathways a barrier for the integration of palliative Care in Chronic Heart Failure (CHF) and chronic pulmonary obstructive disease (COPD)? A comparison with the case of cancer in Europe.

BACKGROUND: There is a notable inequity in access to palliative care (PC) services between cancer and Chronic Heart Failure (CHF)/Chronic Obstructive Pulmonary Disease (COPD) patients which also translates into discrepancies in the level of integration of PC. By cross-examining the levels of PC integration in published guidelines/pathways for CHF/COPD and cancer in Europe, this study examines whether these discrepancies may be attributed to the content of the guidelines. DESIGN: A quantitative evaluation was made between integrated PC in published guidelines for cancer and CHF/COPD in Europe. The content of integrated PC in guidelines/pathways was measured using an 11 point integrated PC criteria tool (IPC criteria). A statistical analysis was carried out to detect similarities and differences in the level of integrated PC between the two groups. RESULTS: The levels of integration between CHF/COPD and cancer guidelines/pathways have been shown to be statistically similar. Moreover, the quality of evidence utilized and the date of development of the guidelines/pathways appear not to impact upon the PC integration in the guidelines. CONCLUSION: In Europe, the empirically observed imbalance in integration of PC for patients with cancer and CHF/COPD may only partially be attributed to the content of the guidelines/pathways that are utilized for the PC implementation. Given the similarities detected between cancer and CHF/COPD, other barriers appear to play a more prominent role.

Diretrizes curriculares nacionais do curso de graduação em Naturologia / National curriculum guidelines for Undergraduate Course in Naturology

Este documento visa apresentar as Diretrizes Curriculares Nacionais em Naturologia. As Informações aqui descritas se alinham com critérios internacionais de segurança e quallidade de formação. Neste, estão descritas as competências e habilidades básicas e subsidiárias das ações do naturólogo nos diferentes âmbitos de atuação, constituindo o núcleo essencial da prática generalista.(AU)

Revision of the ICH guideline on detection of toxicity to reproduction for medicinal products: SWOT analysis.

SWOT analysis was used to gain insights and perspectives into the revision of the ICH S5(R2) guideline on detection of toxicity to reproduction for medicinal products. The current ICH guideline was rapidly adopted worldwide and has an excellent safety record for more than 20 years. The revised guideline should aim to further improve reproductive and developmental (DART) safety testing for new drugs. Alternative methods to animal experiments should be used whenever possible. Modern technology should be used to obtain high quality data from fewer animals. Additions to the guideline should include considerations on the following: limit dose setting, maternal toxicity, biopharmaceuticals, vaccines, testing strategies by indication, developmental immunotoxicity, and male-mediated developmental toxicity. Emerging issues, such as epigenetics and the microbiome, will most likely pose challenges to DART testing in the future. It is hoped that the new guideline will be adopted even outside the ICH regions.

Influence of patient, physician, and hospital characteristics on the receipt of guideline-concordant care for inflammatory breast cancer.

PURPOSE: Inflammatory breast cancer (IBC) is an aggressive subtype of breast cancer for which treatments vary, so we sought to identify factors that affect the receipt of guideline-concordant care. METHODS: Patients diagnosed with IBC in 2004 were identified from the Breast and Prostate Cancer Data Quality and Patterns of Care Study, containing information from cancer registries in seven states. Variation in guideline-concordant care for IBC, based on National Comprehensive Cancer Network (NCCN) guidelines, was assessed according to patient, physician, and hospital characteristics. RESULTS: Of the 107 IBC patients in the study without distant metastasis at the time of diagnosis, only 25.8% received treatment concordant with guidelines. Predictors of non-concordance included patient age (≥70 years), non-white race, normal body mass index (BMI 18.5-25 kg/m(2)), patients with physicians graduating from medical school >15 years prior, and smaller hospital size (<200 beds). IBC patients survived longer if they received guideline-concordant treatment based on either 2003 (p=0.06) or 2013 (p=0.06) NCCN guidelines. CONCLUSIONS: Targeting factors associated with receipt of care that is not guideline-concordant may reduce survival disparities in IBC patients. Prompt referral for neoadjuvant chemotherapy and post-operative radiation therapy is also crucial.

CiPA: Ongoing testing, future qualification procedures, and pending issues.

INTRODUCTION: The comprehensive in vitro proarrhythmia assay (CiPA) is a nonclinical, mechanism-based paradigm for assessing drug proarrhythmic liability. TOPICS COVERED: The first CiPA assay determines effects on cloned human cardiac ion channels. The second investigates whether the latter study-generated metrics engender proarrhythmic markers on a computationally reconstructed human ventricular action potential. The third evaluates conclusions from, and searches possibly missed effects by in silico analysis, in human stem cell-derived cardiomyocytes (hSC-CMs). CiPA ad hoc Expert-Working Groups have proposed patch clamp protocols for seven cardiac ion channels, a modified O'Hara-Rudy model for in silico analysis, detailed procedures for field (MEA) and action potential (VSD) measurements in hSC-CMs, and 29 reference drugs for CiPA assay testing and validation. DISCUSSION: CiPA adoption as drug development tool for identifying electrophysiological mechanisms conferring proarrhythmic liability to candidate drugs is a complex, multi-functional task requiring significant time, reflection, and efforts to be fully achieved.

Características, benefícios e consequências dos algoritmos deminimização da estimulação do ventrículo direito por dispositivos de estimulação cardíaca artificial / Characteristics, benefits and consequences of right ventricle stimulation minimizing algorithms by artificial cardiac pacing devices

Os dispositivos implantáveis de estimulação cardíaca artificial (marcapasso definitivo, cardiodesfibriladore terapia de estimulação multissítio para ressincronização cardíaca) têm benefícios bem estabelecidos e indicações sem expansão. Diversos estudos e publicações têm demonstrado que a estimulação cardíaca artificial convencional não é isenta de efeitos adversos (dissincronia ventricular, risco de insuficiência cardíaca e mortalidade). O progresso tecnológico da eletroterapia cardíaca trouxe novos algoritmos e estratégias de programação dos dispositivos, particularmente os que minimizam a estimulação do ventrículo direito por programação do intervalo atrioventricular. Atualmente, tanto para portadores de marcapasso definitivo como, particularmente, para portadores de cardiodesfibrilador implantável, são recomendadas estratégias que explorem ao máximo a condução atrioventricular intrínseca, quando esta é confiável, com o objetivo de produzir complexos com QRS estreito, evitando as potenciais consequências deletérias da ativação artificial do ventrículo direito. Esta revisão aborda as diferenças entre sequência atrioventricular e sincronia atrioventricular produzidas por esses algoritmos, e o surgimento de um outro virtual conflito de paradigmas: permitir intervalos atrioventriculares não fisiológicos, gerando potencialmente dissincronia atrioventricular mas com QRS estreito, ou estimular artificialmente o ventrículo direito com intervalo atrioventricular fisiológico e QRS largo?.

Implantable artificial cardiac pacing devices (permanent pacemakers, cardioverter-defibrillators and multisite pacing for cardiac resynchronization therapy) have well-established benefits and expanding indications. Several studies and publications have demonstrated that conventional artificial cardiac pacing is not free from adverse effects (ventricular desynchronization, risk of heart failure and mortality). Technological advances in cardiac electrotherapy have led to new algorithms and device programming strategies, particularly those that minimize right ventricle pacing by atrioventricular interval programming. Currently and when ever reliable, strategies that explore intrinsic atrioventricular conduction to a maximum are recommended for carriers of permanent pacemakers and implantable cardioverter-defibrillators to avoid the potential deleterious consequences of artificial right ventricle activation. This review addresses the differences between atrioventricular synchrony and atrioventricular sequencing produced by these algorithms and the emergence of another virtual paradigm conflict: should weallow long, non-physiological, atrioventricular intervals, potentially generating atrioventricular desynchronization with a narrow QRS or artificially stimulate the right ventricle with a physiological atrioventricular interval and awide QRS?.

The clinical use of vitamin D metabolites and their potential developments: a position statement from the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO) and the International Osteoporosis Foundation (IOF).

Several compounds are produced along the complex pathways of vitamin D3 metabolism, and synthetic analogs have been generated to improve kinetics and/or vitamin D receptor activation. These metabolites display different chemical properties with respect to the parental or native vitamin D3, i.e., cholecalciferol, which has been, so far, the supplement most employed in the treatment of vitamin D inadequacy. Hydrophilic properties of vitamin D3 derivatives facilitate their intestinal absorption and their manageability in the case of intoxication because of the shorter half-life. Calcidiol is a more hydrophilic compound than parental vitamin D3. Active vitamin D analogs, capable of binding the vitamin D receptor evoking vitamin D-related biological effects, are mandatorily employed in hypoparathyroidism and kidney failure with impaired 1α-hydroxylation. They have been shown to increase BMD, supposedly ameliorating calcium absorption and/or directly affecting bone cells, although their use in these conditions is jeopardized by the development of hypercalciuria and mild hypercalcemia. Further studies are needed to assess their overall safety and effectiveness in the long-term and new intermittent regimens, especially when combined with the most effective antifracture agents.

Uranium in drinking-water: a unique case of guideline value increases and discrepancies between chemical and radiochemical guidelines.

BACKGROUND: Uranium represents a unique case for an element naturally present in the environment, as its chemical guideline value in drinking water significantly increased from 2 µg/L in 1998 up to 15 µg/L in 2004 and then to 30 µg/L in 2011, to date corresponding to a multiplication factor of 15 within a period of just 13 years. OBJECTIVES: In this commentary we summarize the evolution of uranium guideline values in drinking-water based on both radiological and chemical aspects, emphasizing the benefit of human studies and their contribution to recent recommendations. We also propose a simpler and better consistency between radiological and chemical values. DISCUSSION: The current chemical guideline value of 30 µg/L is still designated as provisional because of scientific uncertainties regarding uranium toxicity. During the same period, the radiological guideline for (238)U increased from 4 Bq/L to 10 Bq/L while that for (234)U decreased from 4 Bq/L to 1 Bq/L. These discrepancies are discussed here, and a value of 1 Bq/L for all uranium isotopes is proposed to be more consistent with the current chemical value of 30 µg/L. CONCLUSION: Continuous progress in the domains of toxicology and speciation should enable a better interpretation of the biological effects of uranium in correlation with epidemiological human studies. This will certainly aid future proposals for uranium guideline values.