Evaluation of a Comprehensive Skin Toxicity Program for Patients Treated With Epidermal Growth Factor Receptor Inhibitors at a Cancer Treatment Center.

Importance: Up to 90% of patients treated with an epidermal growth factor receptor inhibitor (EGFRi) experience cutaneous toxic effects that are negatively associated with quality of life and lead to treatment interruptions. The Skin Toxicity Evaluation Protocol With Panitumumab trial found reduced incidence of skin toxicity and quality of life impairment with preemptive use of doxycycline hyclate, topical corticosteroids, moisturizers, and sunscreen, demonstrating the benefit of prophylactic treatment for skin toxicity. Objective: To evaluate the association of a comprehensive skin toxicity program with adherence to prophylaxis guidelines for the prevention of EGFRi-associated cutaneous toxic effects. Design, Setting, and Participants: A retrospective cohort study was conducted of all adult patients receiving at least 1 dose of cetuximab at the Dana-Farber Cancer Institute in the calendar year 2012 (2 years after publication of the Skin Toxicity Evaluation Protocol With Panitumumab) or the calendar year 2017 (2 years after full implementation of the Skin Toxicities from Anticancer Therapies program). Main Outcomes and Measures: Primary outcomes were rate of preemptive rash treatment and selection of preemptive agents. Secondary outcomes were incidence of rash, rates of rescue treatments, rates of cetuximab dose changes or interruptions, and overall survival at 2 years. Results: There were 118 patients (85 men; median age, 62.4 years [range, 23.5-91.7 years]) treated with cetuximab in 2012 and 90 patients (70 men; median age, 62.5 years [range, 30.7-90.5 years]) treated with cetuximab in 2017; 11 patients (9%) in 2012 and 31 patients (34%) in 2017 were treated at Dana-Farber Cancer Institute affiliate sites. At cetuximab treatment initiation, 29 patients (25%) in 2012 and 42 patients (47%) in 2017 were prophylactically treated for skin toxicity (P < .001). From 2012 to 2017, preemptive tetracycline use (13 of 29 [45%] to 30 of 42 [71%]; P = .02) and topical corticosteroid use (2 of 29 [7%] to 24 of 42 [57%]; P < .001) increased and topical antibiotic use (23 of 29 [79%] to 18 of 42 [43%]; P = .002) decreased. There was no significant difference in incidence of rash by prophylaxis status. Patients prescribed prophylactic treatment were 94% less likely to require a first rescue treatment for rash (adjusted odds ratio, 0.06; 95% CI, 0.02-0.16; P < .001), 74% less likely to require a second rescue treatment for rash (adjusted odds ratio, 0.26; 95% CI, 0.08-0.83; P = .02), and 79% less likely to experience a cetuximab dose change or interruption (adjusted odds ratio, 0.21; 95% CI, 0.06-0.81; P = .02) than patients not prescribed prophylactic treatment, adjusting for treatment site and year. Conclusions and Relevance: Dermatologists can add value to oncology care by raising awareness of appropriate treatment options and increasing adherence to evidence-based prophylaxis protocols for EGFRi-associated rash, which is associated with decreased interventions and toxicity-associated chemotherapy interruptions.

Brief evidence-based interventions for universal child health services: a restricted evidence assessment of the literature.

BACKGROUND: Universal child health services (UCHS) provide an important pragmatic platform for the delivery of universal and targeted interventions to support families and optimize child health outcomes. We aimed to identify brief, evidence-based interventions for common health and developmental problems that could be potentially implemented in UCHS. METHODS: A restricted evidence assessment (REA) of electronic databases and grey literature was undertaken covering January 2006 to August 2019. Studies were eligible if (i) outcomes related to one or more of four areas: child social and emotional wellbeing (SEWB), infant sleep, home learning environment or parent mental health, (ii) a comparison group was used, (iii) universal or targeted intervention were delivered in non-tertiary settings, (iv) interventions did not last more than 4 sessions, and (v) children were aged between 2 weeks postpartum and 5 years at baseline. RESULTS: Seventeen studies met the eligibility criteria. Of these, three interventions could possibly be implemented at scale within UCHS platforms: (1) a universal child behavioural intervention which did not affect its primary outcome of infant sleep but improved parental mental health, (2) a universal screening programme which improved maternal mental health, and (3) a targeted child behavioural intervention which improved parent-reported infant sleep problems and parental mental health. Key lessons learnt include: (1) Interventions should impart the maximal amount of information within an initial session with future sessions reinforcing key messages, (2) Interventions should see the family as a holistic unit by considering the needs of parents with an emphasis on identification, triage and referral, and (3) Brief interventions may be more acceptable for stigmatized topics, but still entail considerable barriers that deter the most vulnerable. CONCLUSIONS: Delivery and evaluation of brief evidence-based interventions from a UCHS could lead to improved maternal and child health outcomes through a more responsive and equitable service. We recommend three interventions that meet our criteria of "best bet" interventions.

Mapa de Evidência: efetividade clínica da Prática da Meditação / Evidence Map: clinical effectiveness of Meditation / Mapa de Evidência: efetividad clínica de la Práctica de la Meditación

O mapa apresenta uma visão geral das evidências sobre os efeitos da Meditação para diversas condições clínicas e de saúde da população em geral. A partir de uma ampla busca bibliográfica de estudos publicados e não publicados, foram incluídos no Mapa 191 revisões (78 revisões sistemáticas, 110 metanálises, 2 metassínteses e 1 revisão integrativa). Sobre os tipos de meditação: 147 revisões avaliaram resultados a partir de técnicas de mindfulness ou derivados, 34 revisões avaliaram meditação geral, 8 revisões meditação transcendental, 3 revisões técnicas de compaixão e 1 revisão avaliou práticas de atenção focada. Todos os estudos foram selecionados, avaliados, caracterizados e categorizados por pares de pesquisadores da área de Meditação.

El mapa muestra una vista general de las experiencias sobre los efectos de la meditación para diversas condiciones clínicas y de la salud de la población en general. A partir de una amplia búsqueda bibliográfica de estudios publicados y no publicados, fueron incluidas 191 revisiones: 78 revisiones sistemáticas, 110 metanálises, 2 metassínteses y 1 revisión integrativa. Sobre los tipos de meditación: 147 revisiones disponibles resultados de partir de técnicas de mindfulness o derivados, 34 revisiones disponibles meditación general, 8 revisiones medita trascendental, 3 revisiones técnicas de comparación y 1 revisión acerca prática de atención focada. Todos los estudios fueron seleccionados, evaluados, y caracterizados por pares de investigadores del área de Meditación.

The map provides an overview of the evidence on the effects of Meditation for various clinical and health conditions of the general population. From a wide bibliographic search of published and unpublished studies, 191 reviews were included in the Map: 78 systematic reviews, 110 meta-analyzes, 2 meta-syntheses and 1 integrative review. About types of meditation: 147 reviews evaluated results for mindfulness techniques or derivatives, 34 reviews evaluated general meditation, 8 reviews transcendental meditation, 3 compassion technique and 1 review evaluated practices of focused attention. All studies were selected, evaluated, characterized and categorized by pairs of researchers in the area of ​​Meditation.

Translational hurdles with cannabis medicines.

PURPOSE: Internationally, there has been widespread medical use of cannabis medicines before rigorous evaluations in randomised controlled trials (RCTs). Some advocates of medicinal use of cannabis argue that real-world evidence (RWE) can be a substitute for or at least supplement evidence from RCTs. We explore the utility, limitations and impact of RWE in the translation of cannabis medicines research into clinical practice using the established literature. METHODS: A literature search was performed via Embase and Medline using a diverse range of cannabinoid and RWE search terms. The review provides a snapshot of cannabis medicine RWE initiatives from around the world. RESULTS: Diverse and novel sources of real-world data and RWE include international cannabis registries, surveys, post-marketing data collection and use of electronic or digital health records. The strengths and limitations of using RWE in translational research are highlighted, along with the identification of barriers to RCTs involving cannabis medicines. CONCLUSIONS: RWE promises to play a significant role in the evaluation of cannabis medicines around the world. When used appropriately RWE may complement RCT data by providing valuable insights into cannabis medicine safety and effectiveness. TAKE HOME MESSAGES: It is important that real-world evidence (RWE) is used to complement rather than replace randomised controlled trial (RCT) evidence on cannabis medicines. Technological advances have created the opportunity to explore diverse and novel sources of cannabis medicine RWE. Although RWE may be more reflective of real-world clinical practice, it cannot provide conclusive evidence of the safety and efficacy of cannabis medicines. While acknowledging its limitations, RWE may nonetheless provide some guidance on safety and adverse events of cannabis medicines. RWE has already had a significant impact on the regulation of cannabis medicines.

Radiotherapy Utilization for Patients Over Age 60 With Early Stage Breast Cancer.

INTRODUCTION: Recent studies have questioned the relative benefit of radiotherapy (RT) for older patients with favorable breast cancer given the lack of survival benefit and marginal local control benefit. Despite the 2004 National Comprehensive Cancer Network (NCCN) guidelines advocating for the option of hormonal therapy alone, trends in utilization rates of RT in this group are not well-documented. We analyzed our institutional experience with implementation of the guidelines over time. MATERIAL AND METHODS: We identified 564 patients aged ≥ 60 years with favorable breast cancer treated with breast conserving surgery from 2000 to 2017. Patients met criteria for Cancer and Leukemia Group B (CALGB) 9343, Postoperative Radiotherapy in Minimum Risk Elderly (PRIME II), or the very-low risk cohort identified in the Toronto-British Columbia study. Multivariable logistic regression analysis was performed to assess the magnitude of association between omission status, grade, and tumor size while controlling for age and year of diagnosis. RESULTS: Overall RT omission rates were 17.6% prior to the 2004 NCCN update and 45% after the publication of the 10-year CALGB data in 2013. The overall RT omission rate was 29%. Patients with grade 1 to 2 histology (odds ratio, 3.2; 95% confidence interval, 1.3-7.7; P = .01) and tumors < 1 cm (odds ratio, 1.60; 95% confidence interval, 0.4-0.9; P = .007) were more likely to omit RT than those with higher grade or larger tumors. CONCLUSIONS: We observed a slight decrease in the use of RT over time, suggesting a move towards adoption of the NCCN guidelines. There remains a fundamental need to continue to individualize breast cancer care based on risk stratification and make evidenced-based treatment recommendations with equitable use of health care resources.

Long-term Risk of Colorectal Cancer and Related Death After Adenoma Removal in a Large, Community-based Population.

BACKGROUND & AIMS: The long-term risks of colorectal cancer (CRC) and CRC-related death following adenoma removal are uncertain. Data are needed to inform evidence-based surveillance guidelines, which vary in follow-up recommendations for some polyp types. Using data from a large, community-based integrated health care setting, we examined the risks of CRC and related death by baseline colonoscopy adenoma findings. METHODS: Participants at 21 medical centers underwent baseline colonoscopies from 2004 through 2010; findings were categorized as no-adenoma, low-risk adenoma, or high-risk adenoma. Participants were followed until the earliest of CRC diagnosis, death, health plan disenrollment, or December 31, 2017. Risks of CRC and related deaths among the high- and low-risk adenoma groups were compared with the no-adenoma group using Cox regression adjusting for confounders. RESULTS: Among 186,046 patients, 64,422 met eligibility criteria (54.3% female; mean age, 61.6 ± 7.1 years; median follow-up time, 8.1 years from the baseline colonoscopy). Compared with the no-adenoma group (45,881 patients), the high-risk adenoma group (7563 patients) had a higher risk of CRC (hazard ratio [HR] 2.61; 95% confidence interval [CI] 1.87-3.63) and related death (HR 3.94; 95% CI 1.90-6.56), whereas the low-risk adenoma group (10,978 patients) did not have a significant increase in risk of CRC (HR 1.29; 95% CI 0.89-1.88) or related death (HR 0.65; 95% CI 0.19-2.18). CONCLUSIONS: With up to 14 years of follow-up, high-risk adenomas were associated with an increased risk of CRC and related death, supporting early colonoscopy surveillance. Low-risk adenomas were not associated with a significantly increased risk of CRC or related deaths. These results can inform current surveillance guidelines for high- and low-risk adenomas.

Timing of Palliative Care in Colorectal Cancer Patients: Does It Matter?

BACKGROUND: Palliative care can improve end-of-life care and reduce health care expenditures, but the optimal timing for initiation remains unclear. We sought to characterize the association between timing of palliative care, in-hospital deaths, and health care costs. METHODS: This is a retrospective cohort study including all patients who were diagnosed and died of colorectal cancer between 2004 and 2012 in Manitoba, Canada. The primary exposure was timing of palliative care, defined as no involvement, late involvement (less than 14 d before death), early involvement (14 to 60 d before death), and very early involvement (>60 d before death). The primary outcome was in-hospital deaths and end-of-life health care costs. RESULTS: A total of 1607 patients were included; 315 (20%) received palliative care and 162 (10%) died in hospital. Compared to those who did not receive palliative care, patients with early and very early involvement experienced significantly decreased odds of dying in hospital (OR 0.21 95% CI 0.06-0.69 P = 0.01 and OR 0.11 95% CI 0.01-0.78 P = 0.03, respectively) and significantly lower health care costs. There were no significant differences in in-hospital deaths and health care costs between patients without palliative care and those who received late palliative care. CONCLUSIONS: Early palliative care involvement is associated with decreased odds of dying in hospital and lower health care utilization and costs in patients with colorectal cancer. These findings provide real-world evidence supporting early integration of palliative care, although the optimal timing (early versus very early) remains a matter of debate.

Thematic Analysis of Persian Documents in the Field of Quran Study and Medicine in National Scientific-Research Journals from 1992 to 2013 "An Opportunity for Evidence Based Decision Making".

Several documents have investigated the area of Quran study and medicine from different points of view; the present study has been assessing all the documents about Quran study and medicine, published in Iranian scientific-research journals, to create an opportunity of revising the interventions executed in this areas and targeting the decisions in order to draw a clear and more realistic vision. In this simple review study, scientific-research and general informative websites in the period of 1992-2013 were explored by taking advantage of critical keywords such as Islamic medicine and Islamic lifestyle. After the initial retrieval, 348 articles were finally ready for the evaluation process. Chi-square test was used to assess the significance of patterns differences between years of study. Minimum and maximum numbers of articles were published in 1992 (0.28 %) and 2011 (12.35 %), respectively. The level of execution of studies by using different methods was as follows: about 3.44 % qualitative, 29.59 % cross-sectional descriptive-analytical, 30.45 % review, 1.14 % case-control, 17.52 % experimental, 3.73 % cohort methods and 12.93 % were performed by other methods. The most common subject study was "The effects of fasting and Ramadan on health" (21.83 %). The most important journals hosting this field articles were the journals of medicine and refinement (27.01 %), as well as the Quran and medicine (12.64 %), respectively. Chi-square test showed significant thematic differences during the 21 years of study. Based on the available evidences, the number of descriptive papers was yet more than the analytical, interventional and scientific-comparative articles. Also, the most studies had been reviewing the medical-Islamic documents. This reflects the need for revising the search strategies of Quran study and medicine.

A literature review on the representativeness of randomized controlled trial samples and implications for the external validity of trial results.

Randomized controlled trials (RCTs) are conducted under idealized and rigorously controlled conditions that may compromise their external validity. A literature review was conducted of published English language articles that reported the findings of studies assessing external validity by a comparison of the patient sample included in RCTs reporting on pharmaceutical interventions with patients from everyday clinical practice. The review focused on publications in the fields of cardiology, mental health, and oncology. A range of databases were interrogated (MEDLINE; EMBASE; Science Citation Index; Cochrane Methodology Register). Double-abstract review and data extraction were performed as per protocol specifications. Out of 5,456 de-duplicated abstracts, 52 studies met the inclusion criteria (cardiology, n = 20; mental health, n = 17; oncology, n = 15). Studies either performed an analysis of the baseline characteristics (demographic, socioeconomic, and clinical parameters) of RCT-enrolled patients compared with a real-world population, or assessed the proportion of real-world patients who would have been eligible for RCT inclusion following the application of RCT inclusion/exclusion criteria. Many of the included studies concluded that RCT samples are highly selected and have a lower risk profile than real-world populations, with the frequent exclusion of elderly patients and patients with co-morbidities. Calculation of ineligibility rates in individual studies showed that a high proportion of the general disease population was often excluded from trials. The majority of studies (n = 37 [71.2 %]) explicitly concluded that RCT samples were not broadly representative of real-world patients and that this may limit the external validity of the RCT. Authors made a number of recommendations to improve external validity. Findings from this review indicate that there is a need to improve the external validity of RCTs such that physicians treating patients in real-world settings have the appropriate evidence on which to base their clinical decisions. This goal could be achieved by trial design modification to include a more representative patient sample and by supplementing RCT evidence with data generated from observational studies. In general, a thoughtful approach to clinical evidence generation is required in which the trade-offs between internal and external validity are considered in a holistic and balanced manner.

Clinical research of traditional Chinese medicine in big data era.

With the advent of big data era, our thinking, technology and methodology are being transformed. Data-intensive scientific discovery based on big data, named "The Fourth Paradigm," has become a new paradigm of scientific research. Along with the development and application of the Internet information technology in the field of healthcare, individual health records, clinical data of diagnosis and treatment, and genomic data have been accumulated dramatically, which generates big data in medical field for clinical research and assessment. With the support of big data, the defects and weakness may be overcome in the methodology of the conventional clinical evaluation based on sampling. Our research target shifts from the "causality inference" to "correlativity analysis." This not only facilitates the evaluation of individualized treatment, disease prediction, prevention and prognosis, but also is suitable for the practice of preventive healthcare and symptom pattern differentiation for treatment in terms of traditional Chinese medicine (TCM), and for the post-marketing evaluation of Chinese patent medicines. To conduct clinical studies involved in big data in TCM domain, top level design is needed and should be performed orderly. The fundamental construction and innovation studies should be strengthened in the sections of data platform creation, data analysis technology and big-data professionals fostering and training.

[Construction and thinking of data element standard directory of traditional Chinese medicine clinical pharmacy information].

The aim of this study was to develop the data element standard directory of traditional Chinese medicine (TCM) clinical pharmacy information, to provide application standards and models of TCM clinical pharmacy for the electronic medical record (EMR). The developed line of work is as follows: initially establish research through four forms: literature analysis, questionnaires, discussion groups, expert advice. The research range from the Chinese herbal medicine research, herbal origin, harvesting, processing, identification of traits, physical and chemical identification, modern research, character, taste, Indications, clinical application, processing, dispensing medicine, Chinese medicine specifications, usage, dosage, caution, efficacy indications to small packaging applications, drug research, management and other related issues, including traditional Chinese medicine theory, application and hospital management information; according to the general and part 16 content of the national "Health Information Data Element Standards", and the basic method of extracting data element to study and develop the data element of TCM clinical pharmacy information from the defining content. Correspondingly propose the ideas and methods of construction of the "Data Element Standard Directory of TCM Clinical Pharmacy Information", sort out medicine clinical information data element standard catalog, divided into basic categories, clinical application class, management class three parts, and set norms and standards of identifying data elements, definitions, allowable value of traditional Chinese medicine clinical information, and discuss the sources and standards of information collection, leaving the interface, standardized and scientific terminology, docking with the existing standards, maintenance and management program and oter issues.

Professional networks and EBM use: a study of inter-physician interaction across levels of care.

Physicians around the globe are increasingly encouraged to adopt guidelines, protocols and other scientific material when making clinical decisions. Extant research suggests that the clinicians' propensity to use evidence-based medicine (EBM) is strongly associated with the professional collaborative networks they establish and maintain with peers. In this paper we explore whether and how the connectedness of primary care physicians with colleagues working in hospital settings is related to their frequency of EBM use in clinical practice. We used survey data from 104 pediatricians working in five local health authorities in the Italian NHS. Social network and attributional data concerning single physicians, as well as their self-reported frequency of EBM use, were collected for three major pathologies in pediatric care: asthmatic, gastro-enteric and urinary pathologies. Ordered regression analysis was employed. Our findings documented a positive association between the number of physicians' relationships with hospital colleagues and the frequency of use EBM. Results also indicated that physicians' organizational affiliations influence the frequency of EBM use. Finally, contrary to our expectations, it was found that clinicians' affiliation to formal collaborative arrangements is at odds with the likelihood of reporting higher frequency of EBM use.

Efficacy of Jian'ganle () versus Hugan Pian (), glucuronolactone and reduced glutathione in prevention of antituberculosis drug-induced liver injury.

Evidence-based medicine is advocated by WHO and adopted by developed countries for many years. In China, however, the selection of essential medicine and various medical insurance reimbursement schemes medicine is usually based on experts' experience of prescription practice which is under heavy critics resulting from the lack of related comparative efficacy and evidence-based research. The efficacy of Jian'ganle in prevention of drug-induced liver injury (DILI) caused by antituberculotics was evaluated in this study by comparison with Hugan Pian, glucuronolactone and reduced glutathione. Evidence was provided for relevant sectors such as Ministry for Human Resources and Social Security of the People's Republic of China and National Health and Family Planning Commission of the People's Republic of China to select and renew the Essential Medicine List (EML), the new rural cooperative medical scheme in China (NRCMS) list or the reimbursement list of industrial injury insurance. A total of 189 patients with initial pulmonary tuberculosis were divided into four groups who took antituberculotics combined with Jian'ganle, Hugan Pian, glucuronolactone and reduced glutathione respectively. Their liver function profile including alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin (TBIL), direct bilirubin (DBIL), total protein (TP), albumin (A) and globulin (G) were detected at admission as baseline and after treatment. The Jian'ganle group was compared with the three others by chi-square tests. In an aspect of maintaining bilirubin indexes normal, Jian'ganle was more efficacious than glucuronolactone. And Jian'ganle had a little more efficacy than reduced glutathione to maintain protein indexes normal as well. And the therapeutic regimen of antituberculotics combined with Jian'ganle was the best in treating tuberculosis and preventing DILI at the same time. The study showed that among the four hepatinicas which demonstrated similar prevention of DILI caused by antituberculotics, Jian'ganle has more advantages over the three others to some extent, which provides a reliable basis for health sectors to select and renew the EML, NRCMS List or the reimbursement list of industrial injury insurance.

Randomised controlled trials of veterinary homeopathy: characterising the peer-reviewed research literature for systematic review.

INTRODUCTION: Systematic review of the research evidence in veterinary homeopathy has never previously been carried out. This paper presents the search methods, together with categorised lists of retrieved records, that enable us to identify the literature that is acceptable for future systematic review of randomised controlled trials (RCTs) in veterinary homeopathy. METHODS: All randomised and controlled trials of homeopathic intervention (prophylaxis and/or treatment of disease, in any species except man) were appraised according to pre-specified criteria. The following databases were systematically searched from their inception up to and including March 2011: AMED; Carstens-Stiftung Homeopathic Veterinary Clinical Research (HomVetCR) database; CINAHL; Cochrane Central Register of Controlled Trials; Embase; Hom-Inform; LILACS; PubMed; Science Citation Index; Scopus. RESULTS: One hundred and fifty records were retrieved; 38 satisfied the acceptance criteria (substantive report of a clinical treatment or prophylaxis trial in veterinary homeopathic medicine randomised and controlled and published in a peer-reviewed journal), and were thus eligible for future planned systematic review. Approximately half of the rejected records were theses. Seven species and 27 different species-specific medical conditions were represented in the 38 papers. Similar numbers of papers reported trials of treatment and prophylaxis (n=21 and n=17 respectively) and were controlled against placebo or other than placebo (n=18, n=20 respectively). Most research focused on non-individualised homeopathy (n=35 papers) compared with individualised homeopathy (n=3). CONCLUSION: The results provide a complete and clarified view of the RCT literature in veterinary homeopathy. We will systematically review the 38 substantive peer-reviewed journal articles under the main headings: treatment trials; prophylaxis trials.

Eficacia del método de los Institutos para el Logro del Potencial Humano (Doman-Delacato) en pacientes con parálisis cerebral infantil / Efficacy of the method of the facilities to achieve human potential (Doman-Delacato) in patients with infant cerebral palsy

Objetivo. La terapia física es fundamental en el tratamiento de pacientes con parálisis cerebral infantil (PCI). Se han utilizado diferentes métodos fisioterápicos: Temple-Fay, Doman-Delacato, Bobath, Kabat, etc. Declaraciones recientes en los medios de comunicación han generado aumento de la demanda de información sobre los posibles beneficios con la terapia de los Institutos para el Logro del Potencial Humano (Método Doman-Delacato). El objetivo de nuestro estudio es revisar la literatura existente sobre el Método Doman-Delacato como tratamiento de la PCI, para determinar la existencia o no de evidencia científica acerca de su eficacia. Estrategia de búsqueda. Se realiza búsqueda bibliográfica en diferentes bases de datos (PubMed, Tripdatabase, Cochrane, PEDro) con las palabras clave Doman-Delacato y parálisis cerebral hasta junio de 2009. Selección de artículos. Se seleccionan 15 artículos adecuados a nuestra búsqueda, incluyendo declaraciones de la Sociedad Americana de Pediatría y de la Sociedad Española de Fisioterapia en Pediatría. Síntesis de resultados y conclusiones. Se trata de un método basado en la teoría de la recapitulación, rechazada por la biología actual, que exige mucha dedicación horaria y que los padres actúen como coterapeutas. Los artículos que propugnan el método adolecen de fallos metodológicos; en los estudios comparativos no existen diferencias significativas entre la aplicación de este método con respecto a otros métodos fisioterápicos estándar. Con base en los estudios realizados hasta la fecha, no se puede determinar la eficacia del método. Son necesarios estudios bien diseñados y con un adecuado nivel de evidencia y grado de recomendación (AU)

Aim. Physical therapy constitutes a fundamental part of the treatment for patients with infant cerebral palsy (ICP). Different methods of physical therapy have been used: Temple-Fay, Doman-Delacato, Bobath, Kabat, Rood, Pëto, Le Mitáyer, Votja, etc. Some recent statements in the media increased parents’ demand for information regarding the possible benefits of the Doman-Delacato Method. The aim of our study is to look through the existing literature on the Doman-Delacato Method as a treatment for ICP, in order to prove, or to deny, the existence of scientific evidence regarding its effectiveness. Search strategy. A bibliographic review has been carried out on different databases (PubMed, Tripdatabase, Cochrane, PEDro) with the key words Doman-Delacato and cerebral palsy. Then, the articles founded have been analysed. Study selection. Various articles have been chosen, including statements from the American Academy of Paediatrics, from the Spanish Society of Physiotherapy and former studies that had already been carried out. Conclusions. This is a method based on a theory (recapitulation theory) denied by current biology, hard to put into practice, which demands a lot of hours dedicated to it and demands that the parents, themselves, should act like co-therapists. The articles advocating the method suffer from methodological failures. In those based on comparative studies, there are no significant differences regarding the application of this method compared to other standard methods of physical therapy. The studies need to be well organized and with an adequate level of evidence and recommendation (AU)

Development and classification of an operational definition of complementary and alternative medicine for the Cochrane collaboration.

During the past decade, the Cochrane Collaboration has been an increasingly important source of information on complementary and alternative medicine (CAM) therapies. From 2007 to 2008, the Cochrane CAM Field developed a topics list that allowed us to categorize all 396 Cochrane reviews related to CAM (as of The Cochrane Library, Issue 4, 2009). This topics list is an advance in making Cochrane reviews on CAM topics accessible to the public. In this article, we discuss challenges in developing the topics list, including developing an operational efinition of CAM, deciding which reviews should be included within the CAM Field's scope, developing the structured list of CAM Field-specific topics, and determining where in the topics list the reviews should be placed. Although aspects of our operational definition of CAM are open to revision, a standardized definition provides us with an objective, reproducible, and systematic method for defining and classifying CAM therapies.

Barriers to implementation of evidence-based electrical therapies and the need for outcome research: role of European registries.

Although clinical trial results and the implementation of current guidelines appear to have encouraged progress in the treatment of arrhythmias, great discrepancies still exist between European Society of Cardiology (ESC) member countries. Guidelines are not adhered to for a variety of reasons. This cannot be explained only by economic factors, although these obviously play a substantial role. Other factors responsible for adequate guideline implementation appear to be the lack of trained personnel, the lack of infrastructure, or different health insurance systems. In this complex scenario, the data based on European registries are useful for creating standards and harmonizing the treatment of arrhythmias. Moreover, a summary of registry data, such as presented in the European Heart Rhythm Association (EHRA) White Book, can provide the opportunity to share and exchange information among ESC member countries on specific needs for improvements, reimbursement policy, and training issues.

[15 years of the Kiel Obesity Prevention Study (KOPS). Results and its importance for obesity prevention in children and adolescents]. / 15 Jahre Kieler Adipositas-Präventionsstudie (KOPS). Ergebnisse sowie deren Einordnung und Bedeutung für die Prävention von Adipositas bei Kindern und Jugendlichen.

The Kiel Obesity Prevention Study (KOPS) has been performed since 1996 and aims to characterize determinants and to prevent overweight. A total of 15,251 children and adolescents aged 5-16 years were recruited, of whom 780 and 92, respectively, underwent school-based and family-based interventions. Long-term evaluation of the school-based intervention was available over 4 and 8 years, while family-based intervention was evaluated over 1 year. The prevalence of overweight was 18.8% for the whole KOPS cohort. Determinants of overweight were parental overweight and obesity, low socioeconomic status (SES), early life factors, and lifestyle factors. School-based intervention ameliorated the weight status of children of high SES and of normal weight mothers over the long-term. The intervention effect was small but within the expectable range as calculated from analysis of determinants. Alternative outcome variables (e.g., fat mass) and new evaluation approaches (e.g., excess gain in fat mass) gave no detailed information of the intervention success. Family-based intervention showed that even with this individual approach children of low SES could not be reached.

Consenso de uso de rituximab en artritis reumatoide. Un documento con recomendaciones basadas en la evidencia / Consensus on the use of Rituximab in Rheumatoid Arthritis. A document with evidence based recommendations

Introducción. El rituximab se ha empleado con éxito en el tratamiento de la artritis reumatoide (AR). Sin embargo, su particular mecanismo de acción, así como la ausencia de pautas concretas en su manejo, hace que se hayan generado dudas sobre su utilización. Objetivo. Establecer recomendaciones que faciliten el empleo de rituximab en la práctica clínica habitual. Métodos. En una primera ronda Delphi, se reunieron nueve reumatólogos expertos que desarrollaron preguntas sobre los temas con mayor duda sobre eficacia y seguridad del fármaco. Estas se adecuaron para hacer una revisión sistemática de la evidencia, que se presentó en una segunda reunión. Se formaron grupos nominales para dar respuesta a cada pregunta y emitir la recomendación. Estas recomendaciones fueron presentadas en una segunda ronda Delphi a un grupo ampliado de reumatólogos expertos. De nuevo se discutieron, se modificaron y se votaron las recomendaciones. Una vez aprobada cada recomendación, se votó el grado de acuerdo. Resultados. Se establecieron 17 recomendaciones: diez de eficacia y siete de seguridad. Todas las recomendaciones de eficacia, excepto tres, presentaron un nivel de evidencia bueno o moderado. Entre las recomendaciones de seguridad, tres presentaron un nivel de evidencia bueno o moderado, mientras que para el resto la evidencia fue indirecta, escasa o nula y son producto de las recomendaciones de los expertos. El grado de acuerdo entre expertos fue elevado para la mayoría de las recomendaciones. Conclusiones. Estas recomendaciones pretenden aclarar dudas sobre el uso de rituximab y establecer pautas de empleo en la práctica clínica. Las recomendaciones de eficacia tienen un nivel de evidencia alto y permiten guiar al médico en decisiones terapéuticas. Las recomendaciones de seguridad tienen un nivel de evidencia menor (AU)

Introduction. Rituximab has been employed successfully for the treatment of Rheumatoid Arthritis (RA). However, its particular mechanism of action, as well as a lack of concrete guidelines for its management have generated doubts on its use. Objective. To establish recommendations that facilitates the use of rituximab in common clinical practice. Methods. In a first Delphi round, 9 expert rheumatologists got together to develop questions on those subjects generating most doubts on the efficacy and safety of the drug. These were adapted to perform a systematic review of the evidence, which was presented in a second meeting. Nominal groups were formed to respond to each question and give a recommendation. These recommendations were presented in a second Delphi round to a larger group of experts in rheumatology. Once again recommendations were discussed, modified and voted upon. Once approved, a vote on the degree of agreement for each recommendation was carried out. Results. 17 recommendations were established, 10 regarding efficacy and 7 safety. All of the efficacy recommendations except 3 presented a good or moderate degree of evidence. Among the safety recommendations, 3 had a good or moderate degree of evidence while in the rest it was indirect, scarce or non-existent and a product of expert recommendation. The degree of agreement between experts was elevated for most of the recommendations. Conclusions. These recommendations attempt to clear doubts on the use of rituximab and establish guidelines for its use in daily practice. Efficacy recommendations have a high degree of evidence, allowing the clinician to be guided in therapeutic decisions. Safety recommendations have a lower degree of evidence (AU)